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New pill aims to tame mania in bipolar disorder

NCT ID NCT06419582

Disease control Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a new drug called BHV-7000 can safely and effectively treat manic episodes in people with bipolar I disorder. 274 hospitalized adults took either the drug or a placebo once daily for 21 days. The main goal was to see if the drug reduced mania symptoms, measured by a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BHV-7000 (a drug taken as a pill once daily)
What this could lead to
If it works, this could provide a new short-term treatment option to quickly reduce manic symptoms in bipolar I disorder.
What could go wrong
This is an early-to-mid stage trial with only 274 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

274 people

The number who actually took part.

Started

May 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Participant must be voluntarily hospitalized for a current manic episode. 2. Male and female participants 18 years to 75 years of age at the time of the screening visit. 3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2. 4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years. 5. Episode of mania must not exceed 12 weeks in duration. 6. Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications). Key Exclusion Criteria: 1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days. 2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder. 3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder Mania

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder

Contacts and locations

Locations

  • Advanced Research Center, Inc.

    Anaheim, California, 92805, United States

  • Arch Clinical Trials

    St Louis, Missouri, 63141, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • CBH Health

    Gaithersburg, Maryland, 20877, United States

  • CIT IE

    Riverside, California, 92506, United States

  • CIT LA

    Bellflower, California, 90706, United States

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Cenexel - RCA

    Hollywood, Florida, 33024, United States

  • Cenexel CNS

    Garden Grove, California, 92845, United States

  • Cenexel CNS

    Torrance, California, 90504, United States

  • Community Clinical Research, Inc.

    Austin, Texas, 78754, United States

  • Floridian Neuroscience Institute

    Miami Lakes, Florida, 33016, United States

  • Hassman Research Institute

    Marlton, New Jersey, 08053, United States

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115, United States

  • LCC Medical Research Inst

    Miami, Florida, 33126, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • NBCR

    North Canton, Ohio, 44720, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407, United States

  • Pillar Clinical Research

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research, LLC

    Bentonville, Arkansas, 72712, United States

  • Precise Clinical Research

    Flowood, Mississippi, 39232, United States

  • ProScience Research Group

    Culver City, California, 90230, United States

  • RBA

    Staten Island, New York, 10329, United States

  • Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site

    Hollywood, Florida, 33021, United States

  • Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site

    Miami Lakes, Florida, 33016, United States

  • Synergy San Diego

    Lemon Grove, California, 91945, United States

  • Uptown Research Institute

    Chicago, Illinois, 60640, United States

  • WIRG

    Little Rock, Arkansas, 72211, United States

  • WRN

    Rogers, Arkansas, 72758, United States

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