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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06423781

Enrollment

233

Registered

2024-05-21

Start date

2024-08-01

Completion date

2026-03-18

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

depression, major depression, antidepressant, major depressive disorder, MDD

Brief 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).

Interventions

DRUGBHV-7000

BHV-7000 75 mg taken once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication	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
Number of Participants With Clinically Significant Laboratory Abnormalities	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.
Number of Participants With Vital Sign Abnormalities	Up to 104 weeks	—
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation	Up to 104 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026