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

ID#: NCT06423781

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Enrolling by invitation

Start Date: August 01, 2024

End Date: November 01, 2027

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