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Completed

NCT Number: NCT06419582

BHV-7000 Acute Treatment of Bipolar Mania

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pillar Clinical Research, LLC, Bentonville, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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).

Key Exclusion Criteria:

  • 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.

Treatment and study plan

BHV-7000

Drug

BHV-7000 75 mg taken once daily for 21 days

Placebo

Drug

Matching placebo taken once daily for 21 days

Primary outcomes

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

    Time frame: Baseline (day 1) 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.

Secondary outcomes

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

    Time frame: Baseline (day 1) to day 21

    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.

  2. Percentage of participants showing treatment response

    Time frame: Baseline (day 1) to day 21

    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.

  3. Percentage of participants showing treatment remission

    Time frame: Baseline (day 1) to day 21

    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.

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

    Time frame: Baseline (day 1) 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.

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

    Time frame: Baseline (day 1) 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.

  6. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21

    Time frame: Baseline (day 1) 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.

  7. Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication

    Time frame: Baseline (day 1) to day 21

    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).

  8. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Baseline (day 1) to day 21

    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.

  9. Number of Participants With Vital Sign Abnormalities

    Time frame: Baseline (day 1) to day 21

  10. Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation

    Time frame: Baseline (day 1) to day 21

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 17, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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