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111 Major Depression Trials Near You
Power is an online platform that helps thousands of Major Depression patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerSmoking Cessation App for Mental Health Disorders
Buffalo, New York
This trial will test a new smartphone app called Quit on the Go, designed to help people with serious mental illness quit smoking. The study will compare this app to traditional methods, with both groups also using nicotine patches and gum. The goal is to see if the app helps more people quit smoking and if it is cost-effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Acute Psychosis, Pregnancy, Others
450 Participants Needed
Brain Stimulation for Depression
Toronto, Ontario
This trial is testing two types of brain stimulation therapies to help people with depression that hasn't improved with other treatments. These therapies use magnetic pulses to stimulate brain areas and improve mood.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use, Unstable Illness, Suicidal, Pregnant, Psychotic, Others
420 Participants Needed
BPL-003 for Treatment Resistant Depression
Rockville, Maryland
This trial tests a nasal spray drug called BPL-003 along with counseling for people whose depression doesn't get better with usual treatments. The drug aims to quickly improve mood, and counseling helps provide emotional support.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Substance Use, Others
Must Not Be Taking:Antidepressants
196 Participants Needed
Active on Power
Osavampator as an Adjunctive Treatment for Depression
Gaithersburg, Maryland
This trial evaluates whether adding the investigational drug Osavampator (also known as NBI-1065845) to existing oral antidepressant therapy can improve depressive symptoms in patients with depression who aren’t adequately responding to their current antidepressant medication(s).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Psychosis, Others
Must Be Taking:Oral Antidepressants
200 Participants Needed
Aticaprant for Depression
Toronto, Ontario
This trial is testing if adding aticaprant to current antidepressants is safe and well-tolerated in people with major depressive disorder. The goal is to see if it can help improve their treatment.
Stay on current meds
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Noncompliance, Allergies To Aticaprant, Others
Must Be Taking:SSRIs, SNRIs
840 Participants Needed
Psilocybin for Depression in Adults with Cancer
Rockville, Maryland
This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose.
In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed.
In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals.
The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Substance Use, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Cannabis, Others
56 Participants Needed
Psilocybin Microdosing for Depression
Toronto, Ontario
This trial tests if very small doses of psilocybin can safely and effectively improve mood in people with major depression who don't respond to or don't want standard treatments. Psilocybin may help by affecting brain chemicals related to mood. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as a breakthrough therapy by the FDA in 2019.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cardiovascular Conditions, Epilepsy, Cancer, Others
Must Not Be Taking:Antidepressants, Opioids, MAO Inhibitors, Others
50 Participants Needed
Theta Burst Stimulation for Alcoholism
Toronto, Ontario
The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 59
Key Eligibility Criteria
Disqualifiers:Unstable Illness, Pregnancy, Dementia, Others
Must Be Taking:Antidepressants, SUD Agonists
40 Participants Needed
rTMS for Major Depressive Disorder
Toronto, Ontario
Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function. For those with depression where medication and psychotherapy have limited benefit, repetitive transcranial magnetic stimulation (rTMS) is an effective treatment. rTMS is a treatment that involves stimulating certain areas of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region. This can be helpful in treating some kinds of psychiatric and neurological disorder, including MDD.
It is not fully known how rTMS changes brain activity to improve symptoms of depression. However, certain brain areas responsible for behaviours impacted by depression are underactive in those with depression. One of those brain regions called the dorsolateral prefrontal cortex (DLPFC), and the investigators will target this region using rTMS. By increasing the activity of these regions, rTMS could potentially improve depression symptoms. For participants receiving rTMS, the investigators will be using the participant's brain scan to better understand brain activity of the brain region stimulated by rTMS before and after treatment.
In this study, the investigators will be collecting detailed information about participants' psychiatric history and depression symptoms, as well as brain scans and saliva samples. The saliva samples will undergo proteomic (having to do with proteins) analyses to identify biological markers ("biomarkers": biological features (e.g.: gene, protein) that can be measured to indicate factors related to rTMS response. The investigators' goal is to use this information to help us understand whether improvement to rTMS depends on brain activity or proteomic factors localized to two specific behaviours impacted by depression: reward processing and working memory (the capacity to hold information temporarily, such as holding a person's address in mind while listening to instructions about how to get there).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bipolar, Psychosis, Drug Abuse, Others
Must Be Taking:Antidepressants
50 Participants Needed
E-field Guided iTBS for Depression
Toronto, Ontario
The purpose of this study is to establish how personalization of repetitive transcranial magnetic stimulation (rTMS) can change markers of brain activity and improve treatment response. To do this, all participants will receive the same active form of treatments, but some of the participants in this study will receive intermittent theta burst stimulation (iTBS) rTMS treatment with standard forms of targeting and intensity, and others will receive iTBS rTMS treatment using personalized magnetic resonance imaging (MRI) and electric field (E-field) modeling measures.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychotic, Neurological Disorders, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants
110 Participants Needed
Insulin Therapy for Depression in Adolescents
Toronto, Ontario
This study will examine if brain insulin resistance is a feature of depression in humans using magnetic resonance imaging (MRI) measures sensitive to brain insulin action. This study will examine adolescents, as depression onset commonly occurs during this age, and the impacts of cumulative medication exposure and other lifestyle-related confounds are also lower in this age group, improving our ability to understand the underlying biology.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:14 - 18
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Diabetes, Liver Disease, Others
Must Not Be Taking:Antipsychotics, Mood Stabilizers
24 Participants Needed
Cannabis Abstinence for Depression
Toronto, Ontario
The prevalence of major depressive disorder (MDD) is \~5.0%, and rates of co-occurring SUDs in these patients approach 40-50%. Specifically, rates of co-morbid cannabis use disorder (CUD) in patients with MDD are elevated 2-3 fold compared to 2.9% in the general population, and is associated with poorer treatment outcomes and impaired cognitive and psychosocial functioning in comparison to MDD patients without CUD. Most studies of cannabis use in MDD are cross-sectional in design, and therefore causal relationships are unclear. This study investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Alcohol, Illicit Substances, Suicidal, Psychotic, Bipolar, Others
Must Be Taking:Antidepressants
52 Participants Needed
Minocycline for Treatment-Resistant Depression
Toronto, Ontario
Major depressive disorder (MDD) is a leading cause of disability worldwide. Up to 50% of patients experience treatment resistant depression (TRD), which accounts for a vast majority of disease burden. Current medications for TRD have limited efficacy and can be associated with intolerable side effects. Therefore, there is a need for finding new treatment targets. Accumulating evidence suggests some patients with MDD including those with TRD, display brain inflammation. Thus, patients with TRD may benefit from medications that can reduce this inflammation. Minocycline is an antibiotic which can cross the blood-brain barrier and has effects on several systems implicated in depression. The principal investigator led the first pilot study of minocycline as an add-on treatment in TRD demonstrating that it led to a significant reduction in depressive symptoms compared to placebo and these findings require replication in a larger sample to confirm the efficacy and tolerability of this treatment approach.
This study is a 12 week, double-blind, placebo-controlled trial of minocycline as add-on treatment for patients suffering from a major depressive episode who have failed to respond to antidepressant treatment, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) and the Antidepressant Treatment History Form (ATHF) at screening. After screening and randomization to the two parallel arms of the trial, 50 patients will receive minocycline added to treatment as usual (TAU) and 50 patients will receive placebo added to TAU. Clinical assessment will include the Hamilton Depression Rating Scale (HRSD-17), Clinical Global Impression scale (CGI), World Health Organization Quality of Life Short Form (WHOQOL-BREF), and Generalized Anxiety Disorder scale (GAD-7), administered at each study visit (baseline, week 2, 6, and 12). Side effects checklists will be undertaken at each visit. Minocycline will be started at 100 mg once daily and will be increased to 100 mg twice daily at two weeks. Secondary outcomes include inflammatory biomarkers measured at baseline, weeks 6 and 12.
This trial will provide further evidence of minocycline's efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
76 Participants Needed
High-Dose iTBS for Depression
Toronto, Ontario
This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
200 Participants Needed
At-Home tDCS for Depression in Pregnancy
Toronto, Ontario
This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Substance Use, Suicidality, Bipolar, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants
156 Participants Needed
Psilocybin-Assisted Psychotherapy for Depression
Toronto, Ontario
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Mania, Psychosis, Substance Use Disorder, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Mood Stabilizers, Others
92 Participants Needed
The overall goals of this project are to assess the feasibility and impact of designing and implementing an at-home intervention aimed at preventing long-term cognitive decline and improving cognition in individuals currently at-risk for developing AD.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:60+
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, OCD, Others
Must Not Be Taking:Anticonvulsants, Psychotropics, Cognitive Enhancers
40 Participants Needed
rTMS for Depression in Autism
Toronto, Ontario
The current clinical trial is focused on evaluating the efficacy of rTMS for treatment of depression in youth and young adults (hereafter called transition aged youth, TAY) with autism spectrum disorder (ASD). The motivation to undertake the current efficacy study is driven by: (1) the substantial impact of depression on TAY with ASD (based on prevalence and contribution to disability/impairment); (2) lack of evidence-based treatments for depression in autism (there are no current trials rigorously evaluating any treatment for depression, i.e., psychotherapeutic, pharmacotherapeutic, brain stimulation); (3) rTMS has demonstrated efficacy in non-autistic individuals to improve symptoms of depression and may be better tolerated in youth than medication treatment; (4) a prior pilot rTMS study focused on treatment of executive function deficits in autism indicated that high frequency rTMS delivered using a rigorous randomized control trial (RCT) protocol can be feasibly implemented in TAY with autism, is well tolerated (mild to moderate adverse effects and low drop out), and has the potential to improve symptoms of depression.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 35
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Seizures, Pregnancy, Others
Must Not Be Taking:Benzodiazepines, Anticonvulsants
80 Participants Needed
Music-based Cognitive Training for Depression
Toronto, Ontario
The investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes of depression. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with major depressive disorder.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
20 Participants Needed
TEST for Major Depression
Bethesda, Maryland
Background:
People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity.
Objective:
To study the safety and feasibility of TEST and assess its antidepressant effects.
Eligibility:
Adults aged 25-64 with major depression that has not been relieved by current treatments.
Design:
Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases. Their medications may be adjusted.
Participants will be interviewed about their depression, side effects, and other treatments they are receiving. They will complete questionnaires. They will give blood and urine samples. Their brain waves and heart rhythm will be recorded. They will take tests of memory, attention, mental functioning, and thinking.
Participants will have magnetic resonance imaging (MRI) scans of the head and brain. They will lie on a table that slides in and out of the scanner. Pictures of brain chemicals will also be taken. They may complete tasks during the MRI.
Participants will receive TEST and/or sham treatments. They may receive optional ECT. An intravenous catheter will be placed in an arm vein to receive general anesthesia. Two electrodes will be placed on the front of their head. An electric current will be passed from the ECT machine through the electrodes. For sham treatments, they will not receive the electric current. Their breathing, heart rate, brain function, blood pressure, and body movements will be measured.
Participants will have 7 follow-up visits over 6 months. Visits can be done via telehealth.
Participation will last for up to 42 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 64
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Abuse, Suicidal, Others
35 Participants Needed
Why Other Patients Applied
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
Ketamine + Virtual Reality for Depression
Toronto, Ontario
Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people. There is therefore a need for new treatments which work quickly and effectively.
One such medication is called ketamine. Studies have shown that ketamine can treat symptoms of depression quickly. This quick action sets ketamine apart from many antidepressants that take weeks to show noticeable effects. One way that it may do this is by creating a transient sense or feeling of being separated from reality, such as seeing or hearing things that are not really there. Another way to create these same feelings is with virtual reality (VR), where a person can feel as though they are entering a 3-dimensional virtual computer-generated world by wearing a special headset or goggles with a computer inside.
In this study, all participants will receive standard ketamine treatments for depression. Half of the participants will also use a VR headset while receiving the ketamine treatments to see if ketamine and VR acting together provide a better treatment for symptoms of depression than ketamine alone.
This is a small pilot trial. The main purpose of this trial is to learn if it is possible to run a larger clinical trial comparing "ketamine and VR" with "ketamine alone", for adults with treatment-resistant depression. The researchers will study this by seeing how many participants take part in the study within 1-2 years, and how many complete the study treatments and tests. The researchers will also compare the two study groups to see if "ketamine and VR" provide a better treatment for symptoms of depression than "ketamine alone".
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Psychosis, Substance Misuse, Pregnancy, Others
Must Be Taking:IV Ketamine
31 Participants Needed
Lemborexant for Insomnia and Depression
Toronto, Ontario
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are:
* Does Lemborexant help participants improve sleep and reduce insomnia symptoms?
* How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)?
Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder.
Participants will:
* Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg)
* Complete clinical assessments and in-person study visits
* Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs)
* Use a wearable device which will be used to collect and monitor physiological data
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Abuse, Bipolar, Others
Must Not Be Taking:Sleep Aids, Antidepressants
30 Participants Needed
Psilocybin for Depression
Toronto, Ontario
Limit: 5000 characters. Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.
The purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Substance Use Disorder, Schizophrenia, Others
Must Not Be Taking:Antidepressants, Antipsychotics
12 Participants Needed
HNK for Treatment-Resistant Depression
Bethesda, Maryland
Background:
Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.
Objective:
To test a study drug (HNK) in people with MDD.
Eligibility:
People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.
Design:
Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.
HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:
They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.
They will receive no drugs for 2 to 3 weeks.
They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.
One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.
...
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Use, Cardiovascular, Others
Must Not Be Taking:MAOIs, Fluoxetine, Aripiprazole, Others
50 Participants Needed
Psilocybin for Depression
Toronto, Ontario
The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin:
1. Changes connectivity within brain networks associated with mood and depression
2. Changes blood flow in brain regions associated with mood and depression
Participants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Psychosis, Others
Must Not Be Taking:Illicit Drugs
50 Participants Needed
Ketamine for Depression
Bethesda, Maryland
Background:
Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.
Objective:
To see if the antidepressant response of ketamine is linked to AMPA receptors.
Eligibility:
Adults ages 18-70 with major depression disorder without psychotic features
Design:
Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam.
Participants will stay at the NIH Clinical Center for 5 weeks.
Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests:
* Blood draws
* Psychological tests
* MRI: Participants will lie in a machine that takes pictures of their brain.
* MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity.
* Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep.
* Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity.
For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Abuse, Serious Illnesses, Others
Must Not Be Taking:Opioids, MAOIs, Fluoxetine, Aripiprazole
70 Participants Needed
Transcranial Magnetic Stimulation for Depression
Toronto, Ontario
This study aims to explore how repetitive transcranial magnetic stimulation (rTMS), a treatment for depression, affects brain function. Depression disrupts the brain's complex network or regions that regulate cognition, emotion, and behavior. rTMS targets these disruptions to restore network function. To measure these effects, researchers will use dry quantitative EEG (qEEG), a new technology that records brain electrical activity quickly (15 minutes compared to 1 hour for traditional EEG) without the need for gel or lengthy electrode setups. This study will evaluate a novel qEEG activity developed by iMediSync (Republic of South Korea) in patients treated with neuromodulation for depression before, during, and up to 12 months after treatment to see if changes in brain activity to identify patterns associated with symptomatic improvement and relapse risk. Findings could help personalize depression treatments by predicting patient outcomes and optimizing care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Substance Use, Neurological Diseases, Hypertension, Others
100 Participants Needed
[18F]PF-06445974 PET Imaging for Depression
Bethesda, Maryland
Background:
Major depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains.
Primary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \[18F\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast.
Eligibility:
People aged 18-70 years with MDD. Healthy volunteers are also needed.
Design:
Participants will have up to 5 clinic visits.
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics.
Participants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder.
Participants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\[18F\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break.
Participants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan.
Some participants may return for a second PET scan; have a lung scan or receive apremilast.
https://nimhcontent.nimh.nih.gov/start/surveys/?s=KE88DXXPLDFHHTF8
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Use, HIV, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Anxiolytics, Others
108 Participants Needed
PET Imaging for Depression
Bethesda, Maryland
Background:
Researchers developed \[11C\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group.
Objective:
To determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).
Eligibility:
People aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years.
Design:
Group A: MDD participants will be studied with the same dose of \[11C\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \[11C\]PS13 and compared to healthy volunteers..
https://nimhcontent.nimh.nih.gov/start/surveys/?s=TJW4RA4WN3LDD988
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Substance Use, Pregnancy, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Anxiolytics, Others
64 Participants Needed
Ketamine for Major Depressive Disorder
Bethesda, Maryland
Background:
Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.
Objective:
Main Study: To study the effects of ketamine in treating depression.
Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry.
To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.
Eligibility:
Main Study: People ages 18-65 with major depressive disorder and healthy volunteers
Ketamine Metabolites Substudy: Healthy volunteers ages 18-65
Design:
Main Study:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.
Phase I (2-7 weeks):
* Gradually stop current medications
* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.
* Mood and thinking tests
* Blood and urine tests
* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.
* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.
* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.
Phase I tests are repeated in Phases II and III and in the final visit.
Phase II (4-5 weeks):
* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.
Phase III (optional):
* 8 infusions of ketamine over 4 weeks
Phase IV (optional):
* Symptoms monitoring for 4 weeks
* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.
Ketamine Metabolites Substudy:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 days.
Study Procedures:
Mood and thinking tests
Blood and urine tests
1 infusion of ketamine
Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Substance Abuse, Others
Must Not Be Taking:Reversible MAOIs, Opioids
150 Participants Needed
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Frequently Asked Questions
How much do Major Depression clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Major Depression clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Major Depression trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Major Depression is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Major Depression medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Major Depression clinical trials?
Most recently, we added Theta Burst Stimulation for Major Depression, Nitrous Oxide for Acute Suicidality and CYB003 for Depression to the Power online platform.
What do the "Power Preferred" and "SuperSite" badges mean?
We recognize research clinics with these awards when they are especially responsive to patients who apply through the Power online platform. SuperSite clinics are research sites recognized for a high standard of rapid and thorough follow-up with patient applicants. Meanwhile, Power Preferred clinics are the top 20 across the entire Power platform, recognized for their absolute top patient experience.
Which clinics have received Power Preferred and SuperSite awards recruiting for Major Depression trials?
The Major Depression clinics currently recognized as SuperSites are: Cenexel CBH (CBH Health) in Gaithersburg, Maryland
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