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

Duration: 3 weeks

274 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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.

My BMI is between 18 and 35.

I am voluntarily in the hospital for a current manic episode.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHV-7000 or placebo for the acute treatment of manic episodes in bipolar disorder I

3 weeks

Inpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+