BHV-7000 Acute Treatment of Bipolar Mania

A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: BHV-7000; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Pillar Clinical Research, LLC
    • Little Rock, Arkansas, United States, 72211
      • WIRG
    • Rogers, Arkansas, United States, 72758
      • WRN
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Bellflower, California, United States, 90706
      • CIT LA
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • Garden Grove, California, United States, 92845
      • CenExel CNS
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Riverside, California, United States, 92506
      • CIT IE
    • Torrance, California, United States, 90504
      • CenExel CNS
  • Florida
    • Hollywood, Florida, United States, 33021
      • Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
    • Hollywood, Florida, United States, 33024
      • Cenexel - RCA
    • Miami, Florida, United States, 33126
      • LCC Medical Research Inst
    • Miami Lakes, Florida, United States, 33016
      • Floridian Neuroscience Institute
    • Miami Lakes, Florida, United States, 33016
      • Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
    • West Palm Beach, Florida, United States, 33407
      • Neuroscience Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch, LLC
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute
    • Chicago, Illinois, United States, 60641
      • Pillar Clinical Research
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Clinical Research
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Arch Clinical Trials
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New York
    • Staten Island, New York, United States, 10329
      • RBA
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • North Canton, Ohio, United States, 44720
      • NBCR
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research, Inc.
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo taken once daily for 21 days
Experimental: BHV-7000	Drug: BHV-7000; BHV-7000 75 mg taken once daily for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7	This objective will be measured by the change in YMRS total score from baseline (day 1) to day 7. 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 7
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication	To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).	Baseline (day 1) to day 21
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score	This objective will be measured by the change in Clinical Global Impression of Severity (CGI-S) score from baseline (day 1) to day 21). The CGI-S is a global index of patient disease severity as rated by the clinician on a scale from 1 to 7, where 7 represents most severe patients.	Baseline (day 1) to day 21
Percentage of participants showing treatment response	Treatment response is defined as greater than or equal to 50% reduction from baseline to day 21 on the YMRS total score. 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
Percentage of participants showing treatment remission	Treatment remission is defined as score of less than or equal to 12 on the 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
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4	This objective will be measured by the change in YMRS total score from baseline (day 1) to day 4. 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 4
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21	This objective will be measured by the change in MADRS total score from baseline (day 1) to day 21. The MADRS, Montgomery-Asberg Rating Scale, measures depression on a 10 item scale. The overall score ranges from 0 to 60. The higher the MADRS score indicates more severe depression.	Baseline (day 1) to day 21
Number of Participants With Clinically Significant Laboratory Abnormalities	To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.	Baseline (day 1) to day 21
Number of Participants With Vital Sign Abnormalities		Baseline (day 1) to day 21
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation		Baseline (day 1) to day 21

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mania; manic episode; mixed episode; bipolar; mixed mania; manic state; bipolar disorder type 1; manic depressive; manic bipolar; mixed features; bipolar episode
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Mood Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mania; Bipolar Disorder
• Other Study ID Numbers: BHV7000-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No