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

NCT06419608 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BHV7000-305
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 62

Brief 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

Keywords

depression; depressed; depressive disorder; major depression; major depressive episode; antidepressant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

  Baseline to Week 6

• Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6

  Baseline to Week 6

• Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1

  Baseline to Week 1

• Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1

  Baseline to Week 1

• Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score

  Baseline to Week 6

Study Arms (2)

BHV-7000

EXPERIMENTAL

Drug: BHV-7000

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BHV-7000 DRUG

BHV-7000 75 mg taken once daily for 6 weeks

BHV-7000

Placebo DRUG

Matching placebo taken once daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biohaven Therapeutics Ltd.: lead

Study Sites (62)

IMA Clinical Research

Phoenix, Arizona, 85012, United States

Location

Pillar Clinical Research, LLC

Little Rock, Arkansas, 72204, United States

Location

WIRG

Little Rock, Arkansas, 72211, United States

Location

WRN

Rogers, Arkansas, 72758, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

CIT LA

Bellflower, California, 90706, United States

Location

IPMG

Chino, California, 91710, United States

Location

WR-PRI Encino

Encino, California, 91316, United States

Location

Collaborative Neuroscience Research, LLC (CenExel - CNS)

Garden Grove, California, 92845, United States

Location

CalNeuro Research Group

Los Angeles, California, 90025, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

CIT IE

Riverside, California, 92506, United States

Location

Lumos Clinical Research Center

San Jose, California, 95124, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Cenexel CNS

Torrance, California, 90504, United States

Location

Pacific Clinical Research Management Group

Upland, California, 91786, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

UConn Health

Farmington, Connecticut, 06030, United States

Location

Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut

Norwich, Connecticut, 06360, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Floridian Neuroscience Institute

Miami Lakes, Florida, 33016, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

K2 Medical Research

Tampa, Florida, 33607, United States

Location

Neuroscience Research Institute

West Palm Beach, Florida, 33407, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Revive Research Institute, Inc.

Elgin, Illinois, 60123, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Headlands Pharmasite

Baltimore, Maryland, 21208, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Copley Clinical

Boston, Massachusetts, 02116, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

Precise Clinical Research

Flowood, Mississippi, 39232, United States

Location

Arch Clinical Trials

St Louis, Missouri, 63141, United States

Location

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Neurobehavioral Research, Inc

Cedarhurst, New York, 11516, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

Berman Clinical

New York, New York, 10029, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

RBA

Staten Island, New York, 10329, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Scranton Medical Institute

Moosic, Pennsylvania, 18509, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners

Austin, Texas, 78737, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75234, United States

Location

Relaro Medical Trials, LLC

Dallas, Texas, 75243, United States

Location

InSite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77373, United States

Location

Aim Trials

Plano, Texas, 75093, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Alpine Reseach Organization

Clinton, Utah, 84015, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Consciousness Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 28, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (62)