BHV-7000 for Bipolar Disorder

Recruiting at 32 trial locations

Overseen By Louis Wagner

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Therapeutics Ltd.

Must not be taking: Antidepressants, Antimanics, Antipsychotics

Disqualifiers: Rapid cycling, Schizophrenia, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

274 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-75 with a BMI of ≥18 and ≤35, diagnosed with bipolar disorder type I. They must have had at least one previous manic episode in the last two years and be hospitalized voluntarily for a current manic episode. Participants need to stop other psychotropic meds during screening.

Inclusion Criteria

My manic episodes last no longer than 12 weeks.

Key

My BMI is between 18 and 35.

Treatment Details

Interventions

• BHV-7000

Trial Overview The study tests if BHV-7000 is safe and effective for treating acute mania in bipolar disorder I patients compared to a placebo. It's designed to see how well it works when participants are experiencing an active manic episode.

Participant Groups

Group I: BHV-7000 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+