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

Biohaven

Status and phase: Invitation-only; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: BHV-7000

Study type: Interventional

Funder types: Industry

Identifiers

NCT06423781

BHV7000-203

Details and patient eligibility

About

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

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. 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.
3. Investigator deems participant at imminent risk of danger to others.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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480 participants in 1 patient group

BHV-7000

Experimental group

Treatment:

Drug: BHV-7000