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)

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: BHV-7000

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85226
      • Reverie Mind, LLC
    • Phoenix, Arizona, United States, 85012
      • Ima Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • WIRG
    • Little Rock, Arkansas, United States, 72204
      • Pillar Clinical Research, LLC
    • Rogers, Arkansas, United States, 72758
      • WRN
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Bellflower, California, United States, 90706
      • CIT LA
    • Chino, California, United States, 91710
      • IPMG
    • Encino, California, United States, 91316
      • WR-PRI Encino
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research, LLC (CenExel - CNS)
    • Los Angeles, California, United States, 90025
      • CalNeuro Research Group
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Riverside, California, United States, 92506
      • CIT IE
    • San Jose, California, United States, 95124
      • Lumos Clinical Research Center, LLC
    • Stanford, California, United States, 94305
      • Stanford
    • Torrance, California, United States, 90504
      • CenExel CNS
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group
    • Walnut Creek, California, United States, 94596
      • Sunwise Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health
    • Norwich, Connecticut, United States, 06360
      • Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Miami Lakes, Florida, United States, 33016
      • Floridian Neuroscience Institute
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc.
    • Tampa, Florida, United States, 33607
      • K2 Medical Research
    • West Palm Beach, Florida, United States, 33407
      • Neuroscience Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch, LLC
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute
    • Elgin, Illinois, United States, 60123
      • Revive Research Institute, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Collective Medical Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Headlands PharmaSite
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Boston, Massachusetts, United States, 02116
      • Copley Clinical
    • Watertown, Massachusetts, United States, 02472
      • Adams Clinical
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Clinical Research
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Arch Clinical Trials
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Ima Clinical Research
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center For Emotional Fitness
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research LLC
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10029
      • Berman Clinical
    • Staten Island, New York, United States, 10329
      • RBA
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Headlands LLC
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Moosic, Pennsylvania, United States, 18509
      • Scranton Medical Institute
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials, LLC
    • Dallas, Texas, United States, 75234
      • FutureSearch Trials of Dallas
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
    • Houston, Texas, United States, 77373
      • Red Oak Psychiatry Associates, PA
    • Plano, Texas, United States, 75093
      • AIM Trials
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Reseach Organization
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BHV-7000	Drug: BHV-7000; BHV-7000 75 mg taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 18, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: depression; MDD; major depressive disorder; antidepressant; major depression
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major
• Other Study ID Numbers: BHV7000-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No