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

January 5, 2026 updated by: Biohaven Therapeutics Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
Time Frame: Baseline to Week 6
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to Week 6
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
Time Frame: Screening through Week 8
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
Time Frame: Screening through Week 8
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
Time Frame: Screening through Week 8
Screening through Week 8
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time Frame: Screening through Week 8
Screening through Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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