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Bipolar I Disorder Clinical Trials

Reviewed by TrialFinderData Editorial Team · Updated

13 recruiting trials for Bipolar I Disorder. Eligibility criteria explained in plain English.

TrialFinderData lists 13 Bipolar I Disorder clinical trials drawn from ClinicalTrials.gov, all of which are currently recruiting participants.

Across the trials that carry a phase, Phase 2 is the largest group at 45% (5 studies); the largest phase groups are Phase 2: 5, Phase 4: 2, Phase 1 / Phase 2: 2, Phase 3: 2.

Research is led by AbbVie (2), Mclean Hospital (2), The University of Hong Kong (1), among the most active sponsors registered for these trials.

The most frequently studied intervention is Placebo (drug, 5 trials), followed by Cariprazine Depot, CIDI-5.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.
13
Total Trials
13
Recruiting Now
2
Phase 3 Trials
10
Sponsors

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Recruiting Trials

Clinical trial data sourced from the ClinicalTrials.gov registry, maintained by the National Library of Medicine. Always consult your doctor before considering any clinical trial.

RECRUITINGNCT06804525

LHC-CIDI-5 in Hong Kong

The World Health Organization Composite International Diagnostic Interview-5th (CIDI-5) is a standardized diagnostic tool used to assess the prevalence of mental and substance use...

Sponsor: The University of Hong KongEnrolling: 25001 location
RECRUITINGPhase 4NCT07213466

Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the...

Sponsor: Mayo ClinicEnrolling: 1001 location
RECRUITINGPhase 1 / Phase 2NCT07540338

A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed...

The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals...

Sponsor: Alzamend Neuro, Inc.Enrolling: 201 location
RECRUITINGPhase 3NCT04777357

A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive...

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the...

Sponsor: AbbVieEnrolling: 38020 locations
RECRUITINGPhase 4NCT05648591

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Sponsor: Vanda PharmaceuticalsEnrolling: 1009 locations
RECRUITINGPhase 2NCT07494305

Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.

Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either...

Sponsor: LB Pharmaceuticals Inc.Enrolling: 32020 locations
RECRUITINGPhase 2NCT06696755

A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar...

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess...

Sponsor: AbbVieEnrolling: 19520 locations
RECRUITINGPhase 3NCT05303064

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar...

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Sponsor: Alkermes, Inc.Enrolling: 22020 locations
RECRUITINGNCT06221852

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric...

Sponsor: Mclean HospitalEnrolling: 501 location
RECRUITINGPhase 1 / Phase 2NCT07185815

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine...

The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine...

Sponsor: Mapi Pharma Ltd.Enrolling: 246 locations
RECRUITINGPhase 2NCT05064319

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be...

Sponsor: Medical University of South CarolinaEnrolling: 681 location
RECRUITINGPhase 2NCT07288320

An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current...

The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are...

Sponsor: Neurocrine BiosciencesEnrolling: 1506 locations
RECRUITINGPhase 2NCT05837104

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as...

Sponsor: Mclean HospitalEnrolling: 401 location

Frequently Asked Questions

There are currently 13 clinical trials for Bipolar I Disorder, with 13 actively recruiting participants. These include trials across all phases from early-stage Phase 1 to late-stage Phase 3.

To join a clinical trial for Bipolar I Disorder, review the eligibility criteria on the trial detail pages, then talk to your doctor about whether a trial is right for you. Your doctor can help you evaluate the potential benefits and risks.

Phase 3 trials are large-scale studies that test whether a treatment is effective and monitor side effects. There are 2 Phase 3 trials for Bipolar I Disorder, representing treatments closest to potential FDA approval.

Clinical trials follow strict safety protocols overseen by Institutional Review Boards (IRBs) and the FDA. Participants are monitored closely and can withdraw at any time. Always discuss risks and benefits with your healthcare provider before enrolling.

Sources: ClinicalTrials.gov, FDA
Last updated:

Trial data sourced from the ClinicalTrials.gov API. This site does not provide medical advice, always talk to your doctor about clinical trial participation.