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)
1 other identifier
interventional
233
1 country
66
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Aug 2024
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2026
CompletedApril 1, 2026
March 1, 2026
1.6 years
May 16, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
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
Up to 104 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
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.
Up to 104 weeks
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
Study Arms (1)
BHV-7000
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Eligible subjects should have successfully completed the Treatment/Randomization Phase of parent studies.
- WOCBP must have a negative urine pregnancy test at Baseline Visit.
- WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the study.
You may not qualify if:
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
- 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.
- Investigator deems participant at imminent risk of danger to others.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Reverie Mind, LLC
Chandler, Arizona, 85226, United States
IMA Clinical Research
Phoenix, Arizona, 85012, United States
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204, United States
WIRG
Little Rock, Arkansas, 72211, United States
WRN
Rogers, Arkansas, 72758, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
CIT LA
Bellflower, California, 90706, United States
IPMG
Chino, California, 91710, United States
WR-PRI Encino
Encino, California, 91316, United States
Collaborative Neuroscience Research, LLC (CenExel - CNS)
Garden Grove, California, 92845, United States
CalNeuro Research Group
Los Angeles, California, 90025, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Anderson Clinical Research
Redlands, California, 92374, United States
CIT IE
Riverside, California, 92506, United States
Lumos Clinical Research Center, LLC
San Jose, California, 95124, United States
Stanford
Stanford, California, 94305, United States
Cenexel CNS
Torrance, California, 90504, United States
Pacific Clinical Research Management Group
Upland, California, 91786, United States
Sunwise Clinical Research
Walnut Creek, California, 94596, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910, United States
UConn Health
Farmington, Connecticut, 06030, United States
Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
Norwich, Connecticut, 06360, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
K2 Medical Research
Tampa, Florida, 33607, United States
Neuroscience Research Institute
West Palm Beach, Florida, 33407, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Revive Research Institute, Inc.
Elgin, Illinois, 60123, United States
Collective Medical Research
Overland Park, Kansas, 66210, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Headlands Pharmasite
Baltimore, Maryland, 21208, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
Copley Clinical
Boston, Massachusetts, 02116, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Adams Clinical
Watertown, Massachusetts, 02472, United States
Precise Clinical Research
Flowood, Mississippi, 39232, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
IMA Clinical Research
Las Vegas, Nevada, 89102, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516, United States
Bioscience Research LLC
Mount Kisco, New York, 10549, United States
Berman Clinical
New York, New York, 10029, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
RBA
Staten Island, New York, 10329, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Summit Headlands LLC
Portland, Oregon, 97210, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Scranton Medical Institute
Moosic, Pennsylvania, 18509, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
Austin, Texas, 78737, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75234, United States
Relaro Medical Trials, LLC
Dallas, Texas, 75243, United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77373, United States
Aim Trials
Plano, Texas, 75093, United States
Grayline Research Center
Wichita Falls, Texas, 76309, United States
Alpine Reseach Organization
Clinton, Utah, 84015, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2024
First Posted
May 21, 2024
Study Start
August 1, 2024
Primary Completion
March 18, 2026
Study Completion
March 18, 2026
Last Updated
April 1, 2026
Record last verified: 2026-03