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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • 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
    • 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
    • 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
  • 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. Subjects experiencing a moderate to severe episode of depression.
2. Subjects experiencing a current episode of depression for at least 2 months.
3. Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
4. Male and Female participants 18 to 75 years of age at the time of consent.
5. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.

Key Exclusion Criteria:

1. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
2. Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
3. Subjects with a history of medical conditions that may interfere with the conduct of the study.
4. Females who are pregnant, breastfeeding or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo taken once daily for 6 weeks
Experimental: BHV-7000	Drug: BHV-7000; BHV-7000 75 mg taken once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6	The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).	Baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score	The CGI-S is a clinician-rated scale to assess disease severity. The scale is scored on 8-point scale (0 [not assessed] to 7 [severe]). A higher score represents a higher severity illness.	Baseline to Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6	The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.	Baseline to Week 6
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1	The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).	Baseline to Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1	The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.	Baseline to Week 1
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score	The Q-LES-Q-SF is a participant self-administered scale to assess the degree of enjoyment and satisfaction experienced in various areas of daily functioning. The form consists of 16 items. Each item is scored on 5-point scale. A higher score represents a higher level of satisfaction and enjoyment (total scores range from 14 to 70).	Baseline to Week 6
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	Screening through Week 8
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.	Screening through Week 8
Number of Participants With Vital Sign Abnormalities		Screening through Week 8
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation		Screening through Week 8

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: depression; depressive disorder; antidepressant; major depression; major depressive episode; depressed
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Mood Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Depression; Depressive Disorder; Depressive Disorder, Major; Consciousness Disorders; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: BHV7000-305

Drug and device information, study documents

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