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20 Bipolar Disorder Trials near Washington, DC
Power is an online platform that helps thousands of Bipolar Disorder 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 PowerOLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder
Washington D.C., District of Columbia
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Seizure Disorder, Diabetes, Others
Must Be Taking:Antipsychotics
220 Participants Needed
OLZ/SAM for Schizophrenia
Washington D.C., District of Columbia
This trial evaluates the safety and tolerability of OLZ/SAM in children and adolescents with schizophrenia or Bipolar I disorder. OLZ/SAM combines olanzapine to manage symptoms and samidorphan to reduce weight gain. Olanzapine is a well-established antipsychotic effective for schizophrenia and bipolar I disorder, but its use is limited by significant weight gain; samidorphan is added to mitigate this side effect.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Pregnancy, Others
Must Be Taking:OLZ/SAM
236 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
KarXT for Bipolar Disorder
Gaithersburg, Maryland
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:BP-II, Major Depression, Substance Use, Others
Must Not Be Taking:Psychotropics
274 Participants Needed
KarXT for Bipolar Disorder
Gaithersburg, Maryland
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)
The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Suicidal Behavior, Rapid Cycling, Substance Use, Others
450 Participants Needed
RAP-219 for Bipolar Disorder
Gaithersburg, Maryland
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Schizoaffective, Substance Use, Others
224 Participants Needed
BHV-7000 for Bipolar Disorder
Gaithersburg, Maryland
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Medical Condition, Adherence Issues, Risk To Self/others
200 Participants Needed
ABBV-932 for Bipolar Disorder
Gaithersburg, Maryland
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder.
ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Study doctors put participants in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide.
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
Trial Status:Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
160 Participants Needed
BHV-7000 for Bipolar Disorder
Gaithersburg, Maryland
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
256 Participants Needed
Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
Gaithersburg, Maryland
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
450 Participants Needed
Lumateperone for Bipolar Mania
Gaithersburg, Maryland
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Dementia, Substance Use, Others
350 Participants Needed
Lumateperone for Pediatric Bipolar Depression
Baltimore, Maryland
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Intellectual Disability, Suicidal Risk, Others
384 Participants Needed
Cariprazine for Bipolar Disorder in Youth
Baltimore, Maryland
This trial is testing the safety and effectiveness of Cariprazine for treating depressive episodes in children and teenagers with bipolar I disorder. The goal is to find out if Cariprazine can help young people with this condition. Cariprazine is an atypical antipsychotic recently approved for the treatment of depressive episodes in adults with bipolar I disorder.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Substance Disorder, Seizures, Others
Must Not Be Taking:Psychotropics, CYP3A4 Inhibitors
380 Participants Needed
Multiple Medications for Bipolar Depression
Baltimore, Maryland
This trial is testing four different medications to find the best treatment for adults with bipolar disorder type 1 who are currently depressed. The medications work by balancing brain chemicals that affect mood. The goal is to help patients recover from depression and stay well.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Manic Episode, Schizophrenia, Substance Use, Others
Must Not Be Taking:Study Medications
2726 Participants Needed
Cognitive Behavioral Therapy for Chronic Pain
Baltimore, Maryland
Chronic musculoskeletal pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic musculoskeletal pain leads to poorer mental and physical health-related functioning, representing a critical obstacle to rehabilitation and recovery for SMI Veterans. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to evaluate nonpharmacological pain management strategies in this population. This study aims to address this research and clinical gap by testing the efficacy of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI and chronic low back pain. The study will primarily evaluate the impact of CBT-CP on pain-related functioning, quality of life, and pain severity. This study will also examine relationships between pain and mental health symptoms, and how these relationships may change with CBT-CP completion.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Acute Pain, Limited Mobility
190 Participants Needed
Cariprazine for Pediatric Schizophrenia
Baltimore, Maryland
This trial is testing the safety and effectiveness of cariprazine in children and teens with schizophrenia, bipolar I disorder, or autism. The goal is to see if the medication is safe and beneficial for use in these young patients.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Major Depressive, Schizoaffective, Intellectual Disability, Others
310 Participants Needed
Cognitive Behavioral Therapy for Serious Mental Illness-related Chronic Pain
Baltimore, Maryland
Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Acute Pain, Limited Mobility
47 Participants Needed
ALTO-100 for Bipolar Depression
Baltimore, Maryland
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
200 Participants Needed
Probiotics for Bipolar Disorder
Towson, Maryland
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
80 Participants Needed
VNS for Bipolar Depression
Baltimore, Maryland
This trial is testing whether VNS Therapy, which sends electrical impulses to the vagus nerve, can reduce depression symptoms in patients who haven't responded to other treatments. The study will observe the effects of VNS therapy over a year. Vagus nerve stimulation (VNS) is a recognized treatment for severe treatment-resistant depression and has shown promising results.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Schizophrenia, Bipolar, Dementia, Others
6800 Participants Needed
Why Other Patients Applied
"I really would love to be normal. A functioning part of society. It is very hard to hold a job with this condition. I need to be steady. I do NOT like my current meds or ones I've tried before, so new therapies are of interest to me. "
EC
Bipolar Disorder PatientAge: 42
"I have suffered from different mental health issues and have not had very good luck with finding what works best for me. My mental illness is seriously hurting my marriage and home life... I've been reading about new research treatments and think that they might work better than traditional treatments. Excited to try."
QQ
Bipolar Disorder PatientAge: 43
"My mania is under control but I still have no way of handling depression. I've been looking into new treatments and I would be so grateful to be able to try one of the latest research treatments. Even if it fails: it's worth a shot, better than giving up. I'm a bit at wit's end."
PW
Bipolar Disorder PatientAge: 30
"I have tried many different drugs in the past. I just want to find something that works. I just want to be happy and content with life. I'm always having "episodes" where I just shut down and cry and get mad. I need to find a drug that helps me live a happier life. I have everything I ever wanted, yet still can't stay happy. Hopefully this trial helps me and other people in these situations. "
QE
Bipolar Disorder PatientAge: 35
"Over 20 years, I've tried 6+ antidepressants and anti-anxiety meds to no avail. Cymbalta is the ONLY one that has ever made a difference (which I can use because I have bipolar 2, not 1) but it had some other side effects. I've been hesitant to try any trials, but also at a deadend of any relief. So, let's give it a shot."
ZJ
Bipolar Disorder PatientAge: 42
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