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Completed
NCT06423781
Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)
Conditions: Major Depressive Disorder
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 233
Sponsor: Biohaven Therapeutics Ltd.
Location: Reverie Mind, LLC Chandler Arizona
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 Criteria
Key Inclusion Criteria:
1. Eligible subjects should 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.
Source: ClinicalTrials.gov (NCT06423781). StuddyBuddy aggregates publicly available trial information.