Bipolar Disorder I Study

Bipolar Disorder I
An Inpatient Study to Evaluate the Effectiveness and Safety of BHV-7000 for Manic Episodes Associated with Bipolar I Disorder

Do you or someone you know have bipolar disorder and are currently dealing with a manic episode?

We are conducting a study to determine whether BHV-7000 is a safe and effective treatment for manic episodes in those with bipolar I disorder.

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Enrolling Patients
Phase 2/3
35 Study Locations
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Who’s Included?


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Length of Study

Up To 7 Weeks
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Post-study Follow Up

2 Weeks

What Is Bipolar Disorder?

Bipolar disorder is a lifelong condition with a wide range of symptoms that negatively impact the lives of people who experience alternating episodes of depression and mania, together described as, “mood episodes.”

People with bipolar disorder struggle with the full spectrum of depression and mania, lows and highs that disrupt life in their own ways, which makes treatment more difficult. Mood episodes have proven difficult to treat with existing medications, often resulting in intolerable side effects that can be as difficult to deal with as the disorder itself, or only incompletely treating symptoms. As medications that treat mood episodes are often continued with the hope of maintaining a treatment effect, intolerable side effects lead to difficulties staying on medication, which often results in mood episode relapse.

  • Participants Must:

  • Be currently experiencing a manic episode with or without mixed depressive features.
  • Current manic episode must not have started more than 12 weeks ago.
  • Have experienced a previous manic episode.
  • Be willing to discontinue all other psychotropic medications before entering the study, unless otherwise allowed.
  • Must be willing to sign into an inpatient study site for the duration of the study.
  • Be between 18 and 75 years of age.
  • Be between a Body Mass Index (BMI) of 18 and 35 kg/m2
  • Participants Must Not:

  • Have a lifetime history of rapid-cycling (6 mood episodes per year).
  • Have a history of neuropsychiatric disorders or medical conditions that that may interfere with the study conduct, which will be reviewed during screening.

Frequently Asked Questions

About 256 people will participate in this study.

The study is being conducted by Biohaven.

The study lasts up to 7 weeks (2 weeks screening, 3 weeks in patient treatment, 2 weeks outpatient safety follow up).

There is a potential for participants who complete the double-blind study to participate in a 52-week open-label extension study.

For participants not rolling over into open-label study, an outpatient safety follow-up visit occurs 2 weeks after last dose of study medication.

If a participant is rolling over, then they will not have a safety follow-up visit and start the open-label study on the last visit of this study.

Visit our See If You Qualify page and fill out the form. A clinician will then contact you to discuss your qualifications.

Learn more about the benefits of joining our trial and see if you qualify today!