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Anti-epileptic agent

BHV-7000 for Bipolar Disorder

Phase 2 & 3
Recruiting
Research Sponsored by Biohaven Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) to day 21

Summary

This trial aims to find out if BHV-7000 is a safe and effective treatment for managing manic episodes in people with bipolar disorder I.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of BHV-7000 aren't specified here, but common treatment-related side effects may include nausea, headache, dizziness, or mood swings. Placebo typically has no direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop taking all my psychiatric medications for the screening.
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I have been diagnosed with bipolar disorder type I recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21
Secondary study objectives
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-7000Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Biohaven Therapeutics Ltd.Lead Sponsor
11 Previous Clinical Trials
4,440 Total Patients Enrolled
1 Trials studying Bipolar Disorder
200 Patients Enrolled for Bipolar Disorder
~57 spots leftby Mar 2025
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