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The trial is taking place at:
I

InSite Clinical Research | DeSoto, TX

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BHV-7000 Acute Treatment of Bipolar Mania

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Biohaven

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Bipolar Disorder

Treatments

Drug: Placebo
Drug: BHV-7000

Study type

Interventional

Funder types

Industry

Identifiers

NCT06419582
BHV7000-204

Details and patient eligibility

About

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.

Enrollment

256 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

256 participants in 2 patient groups, including a placebo group

BHV-7000
Experimental group
Treatment:
Drug: BHV-7000
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

32

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Central trial contact

Chief Medical Officer

Data sourced from clinicaltrials.gov

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