Anxiety

Maryland

34 Anxiety Trials near Maryland

Power is an online platform that helps thousands of Anxiety 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.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
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Fasedienol Nasal Spray for Social Anxiety

Baltimore, Maryland
This Phase 3 clinical trial is designed to evaluate the Fasedienol Nasal Spray (fasedienol) for adults that are 18-65 who suffer from symptoms of social anxiety such as nervousness, worry or fear of judgement. In addition, there is an Open Label Extension phase of the study for patients that choose to participate where use of nasal spray for up to 12 months will be assessed.
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 65

236 Participants Needed

Music Therapy + CBT for Pediatric Anxiety

Bethesda, Maryland
Background: Anxiety disorders are becoming more common among children and teenagers. Anxiety can lead to long-term physical and mental problems, such as depression. Treatments for anxiety disorders include medications as well as cognitive behavioral therapy (CBT); CBT is a form of talking therapy. Both approaches work in only about 50 percent of cases. A new approach, called gaze-contingent music reward therapy (GCMRT), may help. Objective: To find out whether GCMRT combined with CBT is more effective than CBT alone. Eligibility: Children aged 8 to 17 years with separation anxiety disorder; generalized anxiety disorder; or social anxiety disorder. They must be enrolled in protocol 01-M-0192. Design: Participants will come to the clinic once a week for 4 weeks for CBT. Sometimes the participant will meet with the doctor alone; sometimes their parent may be present. They will do some computer-based tasks: They may be asked to push a button when a target appears; they may look at pictures of faces while the computer tracks their eye movements. Participants will take questionnaires each week. They will answer questions about their anxiety symptoms, feelings, and behavior. For the next 8 weeks, participants will participate in both CBT and 1 of 2 types of GCMRT. GCMRT is a computer-based task. Participants will look at pictures with many faces in them; while they do this, pleasant music will play and stop playing over a 12-minute period. Participants will have a final visit in week 13. They will take questionnaires. They will do final research tasks. Each visit lasts about 2 hours.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:8 - 17

150 Participants Needed

Buspirone for Opioid Withdrawal

Baltimore, Maryland
The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2

100 Participants Needed

Group Therapy for Psychosocial Issues

Washington, District of Columbia
Participants are being asked to be in the study if they are the parent or legal guardian of a child (\>1 year or \<18 years old) with a rare condition. The group based psychoeducational intervention is called Rare Group Problem Management Plus. Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes) Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour. Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this. Participants will not receive any materials or money or medication.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

8 Participants Needed

VR Therapy for Anxiety in Brain Tumor Patients

Bethesda, Maryland
Background: Distress, anxiety, and other psychological disorders may be more common in people with primary brain tumors (PBTs). PBTs can affect their symptoms, quality of life, and their tolerance of cancer treatments. Researchers want to learn if virtual reality (VR) technology can help reduce stress and improve mood. VR uses computer technology to make fake experiences and environments that look real. This allows people to escape from their lives and experience more positive thoughts and emotions. Objective: To learn if it is feasible to use a VR relaxation intervention in people with PBTs. Eligibility: Adults 18 and older who have a brain tumor and have recently reported psychological distress during their participation in the Natural History Study (NHS), protocol #16C0151 Design: The VR intervention and all patient-reported outcome measures (PROs) will be done remotely using telehealth. Participants will be mailed a VR headset. This headset looks like a thick pair of goggles that is worn over the eyes. Participants will view computer-generated environments on this VR headset. Participants will fill out symptoms questionnaires at 4 different times points during participation in this study, including questionnaires for the NHS as well as 4 questionnaires unique to this study. There are also optional saliva samples collected at these timepoints. The 4 timepoints are: * Before the VR intervention * After the VR intervention * 1 week later * 4 weeks later Participants will also have a phone interview 1 week after the initial VR interevention, which will last 10 to 15 minutes. Participation lasts 4 to 6 weeks. ...
No Placebo Group

Trial Details

Trial Status:Recruiting

120 Participants Needed

Fluoxetine for Anxiety and Depression

Bethesda, Maryland
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG). Patients will be studied over one year, before and after receiving either one of two standard-of-care treatments: cognitive behavioral therapy (CBT) or fluoxetine, a serotonin reuptake inhibitor (SSRI). Healthy comparisons will be studied at comparable time points. Primary Objectives: To compare healthy youth and symptomatic, medication-free pediatric patients studied prior to receipt of treatment. The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention, memory, and response to motivational stimuli. Secondary Objectives: 1. To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy (CBT) or fluoxetine, as defined by the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Improvement (CGI) Scale. 2. To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy (CBT) or fluoxetine. 3. To document relations among broad arrays of clinical, cognitive, and neural measures Primary Endpoints: Indices of percent-signal change in hypothesized brain regions, comprising amygdala, striatum, and prefrontal cortex (PFC) for each fMRI and MEG paradigm. Secondary Endpoints: 1. Treatment-response as defined by a continuous measure, the Pediatric Anxiety Rating Scale score (PARS), and a categorial measure, the Clinical Global Improvement (CGI) score. 2. Levels of symptoms and behaviors evoked by tasks that engage attention, memory, and elicit responses to motivational stimuli.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:8 - 65

2530 Participants Needed

Adapted Cognitive-Behavioral Therapy + Support for Prenatal Stress & Perinatal Anxiety & Depression

Washington, District of Columbia
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female

700 Participants Needed

CALM Intervention for Childhood Anxiety Disorder

Columbia, Maryland
This trial aims to test a program called CALM, where school nurses help elementary students manage anxiety using special training and materials. The goal is to see if this program can reduce anxiety and improve school performance. The study will compare CALM to a relaxation-only program to determine its effectiveness.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 12

218 Participants Needed

ABBV-932 for Generalized Anxiety Disorder

Gaithersburg, Maryland
Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess how safe and effective ABBV-932 is when added to the antidepressant therapies in adult participants with GAD who have had an inadequate response ADTs. ABBV-932 is an investigational drug being developed for the adjunctive treatment of GAD. Participants will be randomly assigned to receive ABBV-932 or Placebo in addition to their currently prescribed ADTs. There is 1 in 3 chance of participants assigned to Placebo. Approximately 315 adult participants with GAD and inadequate response to ADTs will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 or matching placebo in addition to their prescribed ADT for 6 weeks and then will be followed for an additional 4 week follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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.
Stay on current meds

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65

315 Participants Needed

Epidiolex for Anxiety in Pediatric Epilepsy

Baltimore, Maryland
This is a prospective open label study assessing the efficacy and tolerability of pharmaceutical grade cannabidiol--Epidiolex (R), for the treatment of anxiety in pediatric patients with pediatric epilepsy that has been difficult to treat and requires ongoing use of anticonvulsant medication.
Stay on current meds
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:6 - 17

20 Participants Needed

Mindful Self-Compassion for Anxiety and Depression

Washington, District of Columbia
The study will compare 8-week Mindful Self-Compassion training, compared to a control group that does not receive the intervention, on anxiety and depression symptom severity in patients with diagnosed anxiety disorders (generalized anxiety disorder, social anxiety disorder, and panic disorder) or major depressive disorder.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

40 Participants Needed

RISE Peer Support for Emotional Distress

Chestertown, Maryland
Health care workers (HCW) face distressing work related situations that pose a threat to the HCW's resilience and well-being. Hospital-based peer support programs can improve HCW well-being, but there are few programs and little data for settings outside of hospitals. The program would adapt, implement, and evaluate an evidence-informed peer support program (RISE) in ambulatory practices, rural hospitals, Federally Qualified Health Centers (FQHC), and community based organizations (CBOs). The hypothesis is that the availability of peer support will improve the culture of well-being, and the resilience and well-being of HCW in participating organizations. The research has the potential to improve the quality of life of HCW and the quality of care available to diverse organizations and the populations the HCW serve.
No Placebo Group

Trial Details

Trial Status:Recruiting

1396 Participants Needed

Early Intervention Programs for Adolescent Mental Health

Newark, Delaware
This study follows children into adolescence who were first randomized to intervention condition in infancy.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Age:13 - 17

120 Participants Needed

Cognitive Behavioral Therapy + Psychoeducation for Anxiety in Children With Autism

Baltimore, Maryland
Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:4 - 6

70 Participants Needed

Caffeinated Gum for Sleep Deprivation

Silver Spring, Maryland
While the negative impact of sleep deprivation on cognitive processing and the partial reversal of this phenomenon by caffeine are well known, the types of cognitive processing previously studied have been limited to simple, straight-forward laboratory tasks. It is unclear how sleep deprivation and caffeine affect performance on operationally relevant complex cognitive tasks, like those encountered by working professionals such as doctors. This study aims to uncover how sleep deprivation and caffeine impact two types of clinical reasoning processes encountered by physicians on a daily basis. Previous work from members of our team investigated diagnostic reasoning in medical professionals and discovered that brain activation in executive processing areas was modulated by self-reported sleepiness and burnout and level of expertise (Durning, Costanzo, et al., 2013; Durning et al., 2014, 2015). The current study aims to expand upon those findings by also investigating a potentially more complex type of clinical reasoning, i.e. therapeutic reasoning, and directly manipulating sleep and caffeine use in a controlled sleep laboratory. Medical students, residents, and board-certified physicians will undergo thirty-seven hours of sleep deprivation and ten hours of sleep recovery in the sleep laboratory. During two FMRI scan sessions we will present high-quality validated multiple-choice questions on common patient situations in internal medicine to participants to explore brain activity during therapeutic reasoning compared with diagnostic reasoning. One FMRI scan will occur following a night of sleep deprivation, and another scan will occur following a night of recovery sleep. Additionally, half of the participants will receive caffeine gum during the sleep deprivation period, while the other half will receive placebo gum. This design will allow us to study the effect of sleep deprivation and caffeine on the neural correlates of diagnostic and therapeutic reasoning and performance in general.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 50

42 Participants Needed

Cognitive Behavioral Therapy for Anxiety in Autism

Baltimore, Maryland
Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 17

60 Participants Needed

Mindfulness or Exercise for Mental Health

Baltimore, Maryland
The investigators will be randomizing 150 college student participants with high levels of social media use into either a 1) control condition (no intervention), a 2) mindfulness meditation cognitive intervention, or 3) a social media reduction + exercise replacement intervention. Participants complete intervention activities daily for one week. The investigators will collect self-report and behavioral measures of social media use and related psychological constructs at three time points: baseline, immediately after the intervention period, and one-week after the intervention period.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

150 Participants Needed

Whole Health Intervention for PTSD

Baltimore, Colorado
This trial tests Omnis Salutis, a program for recent veterans of the Afghanistan and Iraq conflicts. The program helps veterans set and share their health goals with doctors and support systems to improve their well-being.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65

238 Participants Needed

Self-Management Intervention for Anxiety in Respiratory Failure Survivors

Baltimore, Maryland
A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients. The main question\[s\] it aims to answer are: * Is this intervention feasible and acceptable in ARF patients? * Is this intervention in the ICU and hospital associated with reduced anxiety symptoms? Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

60 Participants Needed

CBT vs Mindfulness-Based Therapy for Autism

Charlottesville, Virginia
Autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. Depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. This study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). Both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. However, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. Both interventions will be delivered by telehealth.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

300 Participants Needed

Why Other Patients Applied

"I’ve had anxiety issues for years. It affects my life in every possible way and completely ruins my sleep. I would love to find something that helps. I just want to be able to enjoy my life. And finally rest."

JF
Anxiety PatientAge: 69

"I’ve been having a lot of anxiety and memory fog. I had a baby 18 months ago, and my pregnancy was very hard. During that time, I was prescribed sertraline because it was the safest option during pregnancy. It had bad side effects. Since I had my baby, I've tried another drug, but I haven't really improved. It often feels like my head isn’t 100% here. I need to be fully myself because I have two kids to take care of, and I also want to go back to school. With my mind like this, I won’t be able to do it. Hoping for a new option."

OR
Anxiety PatientAge: 40

"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

"I want to try a trial because I've been on numerous, numerous different drugs for my anxiety. It's been almost 4 years since I've been on any medications. But I've noticed a gradual and steady increase in my symptoms. I just want some relief and to start to see the good things that life has to offer."

EQ
Anxiety PatientAge: 55

"I've been struggling with alcoholism and depression on-and-off for about 12 years. I have heard of people have good outcomes for various mental health issues after using psilocybin but would not be willing to try it without a doctor's care. So I'm applying to a trial. "

QJ
Depression PatientAge: 60

Focused Ultrasound for Opioid Use Disorder

Washington, District of Columbia
The goal of this clinical trial is to to inhibit the anterior insula (AI) with low intensity focused ultrasound (LIFU) to determine the causal role for the AI in pain processing, anxiety, and opiate cue-induced craving. The main question\[s\] it aims to answer are: * the safety and tolerability of LIFU delivered bilaterally to AI compared to sham stimulation in individuals with opiate use disorder (OUD), anxiety, and chronic back pain * the effects of LIFU vs sham on measures of pain processing, anxiety symptoms, and opiate cue-induced craving Participants will undergo anatomical MRI, neurological assessment, clinical assessment and patient query to assess the safety and tolerability of LIFU vs sham.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

25 Participants Needed

Stress Management and Resilience Training for Stress in Air Force Personnel

Baltimore, Maryland
This trial examines the effectiveness of the SMART program in helping U.S. Air Force personnel manage stress and build resilience. The program includes practices like gratitude and mindfulness and can be delivered in-person, via video calls, or through computer-based training. The study aims to find out which delivery method is most effective. The SMART program has been previously tested in various settings, including healthcare workers and employees at a medical center, showing significant improvements in stress, resilience, and mindfulness.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased

500 Participants Needed

Acoustic Stimulation for Sleep Deprivation

Silver Spring, Maryland
The purpose of this study is to determine if brief sounds or tones presented within a restricted period of recovery sleep after a period of sleep deprivation will enhance restorative properties and improve performance during a subsequent period of wakefulness.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39

44 Participants Needed

Group Exercise for Psychiatric Hospitalization

Baltimore, Maryland
More research is needed to elucidate the impacts of physical activity interventions on short- and long-term activity and neuropsychiatric symptoms (NPS) in psychiatric inpatients and to support its advantageousness when compared to current standards of care. To investigate the impact of regular exercise on activity level, NPS, and sleep in an inpatient psychiatry unit, the investigators propose a placebo-controlled study with measures of activity, mood, anxiety, energy, and sleep as primary outcomes in 50 psychiatric inpatients at Johns Hopkins Hospital. Given the challenges of maintaining blinded assignment to treatment arm, the investigators will compare patients during two time periods (3 months each): the first is treatment as usual (TAU), the second adds exercise intervention (EXI).

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

60 Participants Needed

Nature-Based + Virtual Mindfulness for Stress in Healthcare Workers

Bethesda, Maryland
This trial aims to reduce stress in healthcare workers treating COVID-19 patients by combining outdoor activities with online mindfulness exercises. The goal is to see if this combination is more effective than either approach alone.
No Placebo Group

Trial Details

Trial Status:Enrolling By Invitation
Trial Phase:Unphased

90 Participants Needed

Family-Centered Palliative Care for Children with Rare Diseases

Washington, District of Columbia
Children with ultra-rare or complex rare diseases are routinely excluded from research studies because of their conditions, creating a health disparity. However, new statistical techniques make it possible to study small samples of heterogeneous populations. We propose to study the palliative care needs of family caregivers of children with ultra-rare diseases and to pilot test a palliative care needs assessment and advance care planning intervention to facilitate discussions about the future medical care choices families are likely to be asked to make for their child.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:1 - 99

48 Participants Needed

Exercise for Concussion

Charlottesville, Virginia
The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are: * Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time? * Does the intensity of the exercise prescription also influence the aforementioned outcomes? Participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.
No Placebo Group

Trial Details

Trial Status:Recruiting
Age:18 - 25

46 Participants Needed

Mindfulness-Based Intervention for Type 1 Diabetes

Washington, District of Columbia
Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 17

200 Participants Needed

Restricted Social Media for Adolescent Mental Health

Washington, District of Columbia
The mental health of adolescents in the United States has seen a steep decline since 2011, roughly coinciding with the increasing popularity of social media and smartphones. But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? In this study, the investigators will conduct the first field experiment in 11-14-year-olds to examine whether, how, and for whom social media harms mental health.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 14

500 Participants Needed

Glycerol Tributyrate for MELAS Syndrome and Optic Neuropathy

Washington, District of Columbia
This is a parallel arm non-randomized dose-escalation, open-label basket exploratory phase 1 clinical trial where Mitochondrial encephalopathy, lactic acidosis, stroke-like episodes (MELAS) and Leber's hereditary optic neuropathy-Plus (LHON-Plus) participants will undergo simultaneous enrollment in two disease-based arms and receive daily oral doses of glycerol tributyrate to assess its safety and potential for efficacy using clinical, biochemical, and molecular evidence. This study will utilize a two-month baseline lead-in phase to establish and document the clinical baseline for each participant in both arms in order to compare the molecular and clinical parameters. This is clinically relevant in light of the high clinical heterogeneity among subjects affected by the same mitochondrial disease (MELAS or LHON-Plus). For ethical concerns prompted by the lack of treatment for these two intractable and progressive mitochondrial diseases, there will not be a placebo control group. Thus, each participant will act as their own control and receive oral doses of glycerol tributyrate, eliminating the need for a placebo. Considering the high clinical heterogeneity among participants affected by MELAS or LHON-Plus and some clinical divergence between MELAS and LHON-Plus, this strategy is beneficial to every enrolled participants, as each will receive the investigational drug, glycerol tributyrate. In addition, this approach will determine the subject-specific maximal optimized dose in a personalized medicine-based approach. After approval of the IRB protocol from the Institutional Review Board Data and signed consent form from all participants, this investigational basket clinical trial has three phases spanning over 20 months: * A baseline lead-in phase (2 months) to collect participant-specific baseline for clinical, biochemical, molecular and metabolic biomarkers that will be monitored throughout the subsequent dose-escalation and clinical phases. * A dose-escalation phase (6 months) to determine the participant-specific maximum tolerated dose (MTD) during which participant-specific clinical and biochemical biomarkers are collected every month. * A clinical phase at a fixed subject-specific MTD dose (12 months) to collect participant-specific clinical, biochemical, molecular and metabolic biomarkers and to perform three scheduled skin biopsies: at the outset, mid-point, and the end of this clinucal phase. We have planned for a 12-month-long clinical phase at a fixed participant-specific MTD considering the absence of reliable predictors that makes idiosyncratic disease-specific symptoms for MELAS and LHON-Plus impossible to forecast among participant for assessing the potential efficacy of glycerol tributyrate by monitoring clinical symptoms specific for each disease. During the 12-month-long time-frame, disease-specific clinical symptoms will be collected as preliminary evidence of efficacy of glycerol tributyrate using disease-specific biomarkers. Finally, discharge procedure during which the clinical investigator will record non-serious adverse events or serious adverse events for 7 or 30 days, respectively, after the last day of study participation.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65

24 Participants Needed

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Bask GillCEO at Power
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How Do Clinical Trials Work?Are Clinical Trials Safe?What Can I Expect During a Clinical Trial?

Frequently Asked Questions

How much do Anxiety clinical trials in Maryland 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 Anxiety clinical trials in Maryland 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 Anxiety trials in Maryland 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 in Maryland for Anxiety 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 in Maryland 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 Anxiety medical study in Maryland?

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 Anxiety clinical trials in Maryland?

Most recently, we added Pediatric Palliative Care for Rare Diseases, Glycerol Tributyrate for MELAS Syndrome and Optic Neuropathy and Mindfulness-Based Intervention for Type 1 Diabetes to the Power online platform.

What is the best fix for anxiety?

There isn’t one magic “fix” for anxiety, but studies show that most people improve with either cognitive-behavioural therapy (CBT) and/or daily medication such as an SSRI or SNRI, chosen together with a qualified clinician. Adding regular exercise, mindfulness or breathing practice, good sleep and limiting caffeine or alcohol can boost results, so think of treatment as a toolbox—start with proven professional help (therapy and possibly medicine) and layer the healthy habits on top for longer-term control.

What does 333 mean for anxiety?

“333” is a fast grounding trick for sudden anxiety: look around and name three things you see, notice three sounds, then deliberately move three body parts (for example, roll your shoulders, wiggle your toes, stretch your fingers). Focusing on simple sights, sounds, and movements pulls your attention out of racing thoughts and signals your nervous system that you’re safe, which can ease the physical surge of anxiety for a few moments. Use it as a quick reset; if anxiety keeps returning or interferes with daily life, add longer-term strategies like CBT, exercise, or speaking with a healthcare professional.

Do anxiety bracelets really work?

Bracelets made of magnets, copper, crystals, or “negative ions” have not been proven to calm anxiety, but a band can still help if you use it as a cue to do something that does work—e.g., press an acupressure point, follow a paced-breathing vibration, or ground yourself with a quick mindfulness check (small studies of these techniques show temporary relief). In other words, the bracelet is a prompt, not the treatment; for lasting improvement pair that prompt with evidence-based care such as cognitive-behavioral therapy, relaxation training, or medication discussed with a healthcare professional.

Does gabapentin treat anxiety?

Gabapentin isn’t FDA-approved for any anxiety disorder, but doctors sometimes prescribe it “off-label” when standard options (talk therapy, SSRIs/SNRIs, or—short term—benzodiazepines) haven’t worked or can’t be used. Small studies suggest it can ease social or short-term situational anxiety at doses of about 900–2,400 mg a day, yet the evidence is modest and it can cause sleepiness, dizziness, and withdrawal if stopped abruptly. If you’re considering it, discuss with your clinician how its uncertain benefits, side-effects, and need for slow tapering stack up against better-studied treatments and non-drug approaches like cognitive-behavioral therapy.

What is the FDA approved device for anxiety?

Strictly speaking, the FDA has not “approved” any device just for anxiety; rather, it has cleared several prescription-only cranial electrotherapy stimulators (CES) through its 510-k process—including Alpha-Stim AID, Fisher-Wallace Stimulator, and Cervella—for short-term relief of anxiety (often along with insomnia or depression). These devices send a very mild electrical current through clips on the earlobes for about 20–60 minutes a day over several weeks, and their use should be discussed with a healthcare professional to be sure they’re safe and appropriate for you.

What drug is used in rapid relief of anxiety?

For symptoms that need relief within minutes to an hour, doctors usually prescribe a short-acting benzodiazepine such as lorazepam or alprazolam; these calm the nervous system quickly but can cause drowsiness and, with repeated use, dependence, so they are meant for short-term or “as-needed” use. Other fast options include the antihistamine hydroxyzine (works in ~30 min) or propranolol for one-time performance anxiety, while longer-term control is handled with medicines like SSRIs and therapy.

What are the 4 R's of anxiety?

Professionals usually mean one of two quick, four-step loops: 1) Recognize the anxious thought or body cue, Reassure yourself with realistic facts, Relax with slow breathing, then Refocus on your task; or 2) Relabel the thought as “just anxiety,” Re-attribute it to a misfiring alarm, Refocus on a chosen activity for a few minutes, and Re-value the thought as unimportant noise. Some wellness articles cite Rest, Relaxation, Replenish, Release, but that version is a general self-care checklist, not an in-the-moment anxiety technique.

What is intense therapy for anxiety?

“Intensive” therapy for anxiety is the same proven treatments (like CBT and exposure exercises) delivered in a much bigger dose—several hours a day for a short stretch—through formats such as weekend “boot-camps,” 3–5-day-a-week intensive outpatient programs, or brief residential stays. This immersive approach is used when anxiety is severe, hasn’t improved with weekly sessions, or rapid progress is needed, and studies show it can match or outperform standard once-a-week therapy. To explore it, ask your provider or insurer about clinics that offer “intensive CBT/ERP,” “IOP,” or “PHP” programs run by licensed anxiety specialists.

Can I live a long life with anxiety?

Yes. Large studies show that untreated, severe anxiety can slightly raise the risk of early death—mainly by increasing suicide risk and unhealthy behaviors—but the effect is small and is greatly reduced when the condition is recognized and treated. People who get evidence-based care (therapy, possible medication), stay active, avoid smoking/drugs, and keep regular medical check-ups typically live just as long as those without anxiety, so focusing on treatment and healthy routines is the key to a long life.

What is the 5 4 3 2 1 anxiety trick?

The 5-4-3-2-1 “grounding” trick is a rapid way to pull your mind out of racing thoughts: name five things you can see, four you can touch, three you hear, two you smell, and one you can taste, taking slow breaths as you go. Engaging each sense crowds out worry signals and anchors you in the present; repeat or shorten the list any time a panic spike or rumination hits. It’s a quick coping tool—helpful in the moment—but if anxiety is frequent or disabling, pair it with ongoing care from a mental-health professional.

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