NCT06419608

Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Biohaven Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	BHV-7000	BHV-7000 75 mg taken once daily for 6 weeks
DRUG	Placebo	Matching placebo taken once daily for 6 weeks

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2024-05-17
• Last updated: 2026-01-07

Locations

62 sites across 1 country: United States

Regulatory

• FDA-regulated drug study