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OpenTrials
Completed

NCT Number: NCT06423781

Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Reverie Mind, LLC, Chandler, Arizona, 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:

  • Eligible subjects should have successfully completed the Treatment/Randomization Phase of parent studies.
  • WOCBP must have a negative urine pregnancy test at Baseline Visit.
  • WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the study.

Key Exclusion Criteria:

  • Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
  • Participant non-compliance with study procedures, study drug or visit attendance in the parent study that the Investigator deems as clinically significant or unacceptable risk potential for this study.
  • Investigator deems participant at imminent risk of danger to others.

Treatment and study plan

BHV-7000

Drug

BHV-7000 75 mg taken once daily

Primary outcomes

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

    Time frame: Up to 104 weeks

    Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication

  2. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Up to 104 weeks

    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.

  3. Number of Participants With Vital Sign Abnormalities

    Time frame: Up to 104 weeks

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

    Time frame: Up to 104 weeks

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Major Depressive Disorder (MDD)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 21, 2024
Registry last updated
Apr 1, 2026

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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