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48 Bipolar Disorder Trials near San Diego, CA
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 PowerCollaborative Decision Skills Training for Serious Mental Illness
San Diego, California
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Neurological Disorder, Violence, Others
119 Participants Needed
Lumateperone for Pediatric Bipolar Depression
San Diego, California
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
Lumateperone for Schizophrenia and Bipolar Disorder
San Diego, California
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Suicidal Risk, Catatonia, Psychotic Features, Others
Must Be Taking:Psychostimulants
500 Participants Needed
Cognitive Training for Serious Mental Illness
San Diego, California
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use, Low IQ, Neurological Illness, Others
80 Participants Needed
Cariprazine for Pediatric Schizophrenia
San Diego, California
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
VNS for Bipolar Depression
San Diego, California
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
BHV-7000 for Bipolar Disorder
Lemon Grove, California
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
APAP for Obstructive Sleep Apnea in Mental Illness
La Jolla, California
This trial is testing a treatment called Positive Airway Pressure (PAP) for adults with serious mental illnesses like schizophrenia and bipolar disorder who also have sleep apnea. PAP treatment uses a machine to help keep the airways open during sleep by providing a steady stream of air through a mask. The study aims to see if this treatment can improve cognitive function and overall health in these patients over several months. Positive Airway Pressure (PAP) is the standard and most effective treatment for obstructive sleep apnea (OSA).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:40 - 70
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Dementia, Neurological Conditions, Others
300 Participants Needed
BHV-7000 for Bipolar Disorder
Lemon Grove, California
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
Lemon Grove, California
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
Peer-Delivered Suicide Prevention for Serious Mental Illness
San Diego, California
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Intoxication, Imminent Hospitalization, Others
69 Participants Needed
Lumateperone for Bipolar Mania
Lemon Grove, California
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
rTMS for Bipolar Disorder
San Diego, California
This trial is testing whether a special type of brain stimulation called high dose spaced theta-burst rTMS can help reduce depression in people with bipolar disorder who haven't responded to other treatments. The study will also look for markers in the brain that can predict who will benefit from this treatment. Theta-burst stimulation (TBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) that has shown similar or greater effects on brain activity compared to standard rTMS.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Psychotic Disorders, Dementia, Others
Must Be Taking:Mood Stabilizers
60 Participants Needed
Power Preferred
ABBV-932 for Bipolar Disorder
Oceanside, California
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
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Positive Drug Screen, Investigational Drug, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Anticonvulsants, Others
160 Participants Needed
Power Preferred
ALTO-100 for Bipolar Depression
Oceanside, California
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.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Unstable Medical Condition, Psychotic Disorder, Substance Use Disorder, Others
Must Be Taking:Mood Stabilizers
200 Participants Needed
Endoxifen for Bipolar Disorder
Orange, California
Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Personality Disorder, Cardiac Conditions, Others
Must Not Be Taking:Antidepressants, Benzodiazepines, Estrogens, Others
490 Participants Needed
KarXT for Bipolar Disorder
Riverside, California
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:Not Yet 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 Mania
Orange, California
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Suicidal Risk, Others
Must Not Be Taking:Psychotropics
274 Participants Needed
KarXT for Bipolar Disorder
Santa Ana, California
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:Not Yet Recruiting
Trial Phase:Phase 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Suicidal Behavior, Rapid Cycling, Substance Use, Others
300 Participants Needed
Cariprazine for Bipolar Disorder in Youth
Orange, California
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
Why Other Patients Applied
"I am hoping to find some medication to finally help me & my mood disorder. I have tried multiple other options over the years but without much luck of controlling the depression or mania."
MM
Bipolar Disorder PatientAge: 40
"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 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
"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
"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
Lumateperone for Bipolar Mania
Orange, California
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
OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder
Anaheim, California
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
Anaheim, California
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
BXCL501 for Pediatric Schizophrenia and Bipolar Agitation
Anaheim, California
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:10 - 17
Key Eligibility Criteria
Disqualifiers:Acute Intoxication, Suicide Risk, Others
Must Not Be Taking:Benzodiazepines, Hypnotics, Antipsychotics
140 Participants Needed
ABBV-932 for Generalized Anxiety Disorder
Los Alamitos, California
This trial tests a new medication called ABBV-932 to see how it works in the body and if it is safe for healthy adults and those with anxiety or bipolar disorder.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
72 Participants Needed
NMRA-335140 for Bipolar Depression
Garden Grove, California
This trial is testing a new medication called NMRA-335140 to see if it can help adults with Bipolar II disorder who are experiencing major depression. The medication aims to improve mood and reduce feelings of depression.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Bipolar I, Schizophrenia, Substance Use, Others
Must Not Be Taking:Antidepressants, Mood Stabilizers
60 Participants Needed
Ketogenic Diet for Bipolar Disorder
Los Angeles, California
The present study is an open trial of ketogenic diets for adolescents and young adults (ages 12-21 yrs) in the depressive or mixed phases of bipolar disorder (BD). The investigators aim to determine whether combining standard of care pharmacological treatment for bipolar spectrum disorders with a 16-week ketogenic diet is well-tolerated and associated with improvements in depression, inflammatory and metabolic indicators, and executive functioning over the study period.
The experimental treatment in this study is a 16-week full ketogenic diet. Four study sites (UCLA, U Cincinnati, U Colorado and U Pittsburgh) will recruit 80 total youth (20 each) from bipolar specialty clinics. All youth eligible for the ketogenic therapy will be provided with the ketogenic diet and standard of care pharmacological treatment. During the diet therapy youth will be seen by a study child/adolescent psychiatrist at least once a month (and more frequently when needed), with the psychiatrist recommending and providing side effects monitoring and pharmacotherapy as clinically indicated.
The youth and caregivers will also meet with an expert dietitian who will coach all youth on maintaining the ketogenic diet (low carbs, high fats, medium protein) and making sure the child is tolerating the diet and getting enough liquid and nutrients, following the practice guidelines of the International Ketogenic Diet Study Group for treating youth. All youth and involved caregivers will also be provided will at least one motivational enhancement session to support them in goal setting and completion of the study elements.
Throughout the study the investigators will assess metabolic (e.g., blood ketones, HOMA-IR) and inflammatory indicators (e.g., C-reactive protein), both for safety reasons and to assess correlates of symptomatic change. Independent evaluators will assess youth every month regarding their symptoms (depression, mania, anxiety, psychosis), psychosocial functioning, and quality of life.
The investigators anticipate that the pilot will transpire over 24 months and be an important step toward establishing feasibility and acceptability of ketogenic therapy for this population, not only in terms of diet administration and compliance but also for obtaining symptomatic, metabolic and inflammatory measurements.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 21
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Eating Disorders, Others
Must Not Be Taking:SGLT-2 Inhibitors, Insulin, Antihypertensives, Others
80 Participants Needed
Ketogenic Diet for Mental Illnesses
Palo Alto, California
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Insulin Dependence, Cardiovascular Dysfunction, Substance Abuse, Others
Must Not Be Taking:Clozapine
120 Participants Needed
aiTBS for Depression
Palo Alto, California
This trial investigates whether aiTBS, a type of brain stimulation using magnetic fields, can help people with bipolar II disorder who haven't responded to other treatments. The treatment targets a specific brain area to improve mood and reduce depression. Accelerated intermittent theta burst stimulation (aiTBS) is a noninvasive neurostimulation technique that shows promise for improving clinical outcomes in treatment-resistant depression.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Epilepsy, Pregnancy, Substance Abuse, Others
Must Be Taking:Mood Stabilizers
60 Participants Needed
(Bay Area Study) Intermittent Fasting for Bipolar Disorder
Berkeley, California
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Depression, Eating Disorder, Substance Use, Others
Must Be Taking:Mood Stabilizers
150 Participants Needed
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