Bipolar Disorder

Cincinnati, OH

14 Bipolar Disorder Trials near Cincinnati, OH

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

KarXT for Bipolar Disorder

Cincinnati, Ohio
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

274 Participants Needed

KarXT for Bipolar Disorder

Cincinnati, Ohio
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

450 Participants Needed

Ketogenic Diet for Bipolar Disorder

Cincinnati, Ohio
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

80 Participants Needed

Lumateperone for Pediatric Bipolar Depression

Cincinnati, Ohio
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

384 Participants Needed

OLZ/SAM vs. Olanzapine for Schizophrenia or Bipolar Disorder

Cincinnati, Ohio
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

220 Participants Needed

OLZ/SAM for Schizophrenia

Cincinnati, Ohio
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

236 Participants Needed

Iloperidone Safety for Adolescent Schizophrenia

Cincinnati, Ohio
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4
Age:12 - 17

100 Participants Needed

Cariprazine for Bipolar Disorder in Youth

Cincinnati, Ohio
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
Age:10 - 17

380 Participants Needed

Cariprazine for Pediatric Schizophrenia

Cincinnati, Ohio
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

310 Participants Needed

Lumateperone for Schizophrenia and Bipolar Disorder

Cincinnati, Ohio
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
No Placebo Group
Pivotal Trial (Near Approval)

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 3
Age:5 - 17

500 Participants Needed

Lumateperone for Bipolar Mania

Cincinnati, Ohio
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

350 Participants Needed

MYDAYIS® for Bipolar Depression

Mason, Ohio
This protocol is a Phase 2 multi-site study which aims to evaluate the safety and effectiveness of MYDAYIS\® as adjunctive therapy for adults with bipolar depression. Results from this study WILL NOT be used to contribute to an approval of MYDAYIS \® for this indication.
Stay on current meds

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 55

90 Participants Needed

BHV-7000 for Bipolar Disorder

Dayton, Ohio
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

200 Participants Needed

BHV-7000 for Bipolar Disorder

Dayton, Ohio
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

256 Participants Needed

Why Other Patients Applied

"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've been experiencing bipolar depression since I was a teenager and have tried many treatments that have not helped: SSRIs (Prozac), Wellbutrin, talk therapy. None worked. I've heard great things about ketamine therapy and would really like to try it. I'd like to access it through a clinical trial."

FM
Bipolar Disorder PatientAge: 38

"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 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

"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

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