BHV-7000 for Bipolar Disorder
Recruiting at 32 trial locations
CM
LW
Overseen ByLouis Wagner
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Biohaven Therapeutics Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial
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.
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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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-7000Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Therapeutics Ltd.
Lead Sponsor
Trials
13
Recruited
4,800+
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