BHV-7000 Acute Treatment of Bipolar Mania

NCT06419582 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BHV7000-204
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

bipolar; mania; manic episode; manic state; bipolar disorder type 1; manic depressive; manic bipolar; mixed features; mixed episode; mixed mania; bipolar episode

Outcome Measures

Primary Outcomes (1)

• Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21

  The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

  Baseline (day 1) to day 21

Secondary Outcomes (10)

• Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

  Baseline (day 1) to day 21

• Percentage of participants showing treatment response

  Baseline (day 1) to day 21

• Percentage of participants showing treatment remission

  Baseline (day 1) to day 21

• Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7

  Baseline (day 1) to day 7

• Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4

  Baseline (day 1) to day 4

Study Arms (2)

BHV-7000

EXPERIMENTAL

Drug: BHV-7000

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BHV-7000 DRUG

BHV-7000 75 mg taken once daily for 21 days

BHV-7000

Placebo DRUG

Matching placebo taken once daily for 21 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be voluntarily hospitalized for a current manic episode.
• Male and female participants 18 years to 75 years of age at the time of the screening visit.
• Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
• 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.
• Episode of mania must not exceed 12 weeks in duration.
• Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).

You may not qualify if:

• 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.
• 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.
• Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (32)

Pillar Clinical Research, LLC

Bentonville, Arkansas, 72712, United States

Location

WIRG

Little Rock, Arkansas, 72211, United States

Location

WRN

Rogers, Arkansas, 72758, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

CIT LA

Bellflower, California, 90706, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Cenexel CNS

Garden Grove, California, 92845, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

CIT IE

Riverside, California, 92506, United States

Location

Cenexel CNS

Torrance, California, 90504, United States

Location

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

Hollywood, Florida, 33021, United States

Location

Cenexel - RCA

Hollywood, Florida, 33024, United States

Location

LCC Medical Research Inst

Miami, Florida, 33126, United States

Location

Floridian Neuroscience Institute

Miami Lakes, Florida, 33016, United States

Location

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

Miami Lakes, Florida, 33016, United States

Location

Neuroscience Research Institute

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Pillar Clinical Research

Chicago, Illinois, 60641, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Precise Clinical Research

Flowood, Mississippi, 39232, United States

Location

Arch Clinical Trials

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

RBA

Staten Island, New York, 10329, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

NBCR

North Canton, Ohio, 44720, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 28, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (32)