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

June 10, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • 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 Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
      • Phoenix, Arizona, United States, 85012
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
      • Rogers, Arkansas, United States, 72758
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Advanced Research Center, Inc.
        • Contact:
      • Bellflower, California, United States, 90706
      • Encino, California, United States, 91316
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Collaborative Neuroscience Research, LLC (CenExel - CNS)
        • Contact:
      • Los Angeles, California, United States, 90025
      • Oceanside, California, United States, 92056
      • Redlands, California, United States, 92374
      • Riverside, California, United States, 92506
      • Torrance, California, United States, 90504
        • Not yet recruiting
        • Cenexel CNS
        • Contact:
      • Upland, California, United States, 91786
        • Not yet recruiting
        • Pacific Clinical Research Management Group
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Not yet recruiting
        • MCB Clinical Research Centers
        • Contact:
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Not yet recruiting
        • UConn Health
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Not yet recruiting
        • Clinical Neuroscience Solutions, Inc
        • Contact:
      • Miami Lakes, Florida, United States, 33016
        • Not yet recruiting
        • Floridian Neuroscience Institute
        • Contact:
      • Orlando, Florida, United States, 32801
        • Not yet recruiting
        • Clinical Neuroscience Solutions, Inc.
        • Contact:
      • Tampa, Florida, United States, 33607
        • Not yet recruiting
        • K2 Medical Research
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Not yet recruiting
        • CenExel iResearch, LLC
        • Contact:
      • Savannah, Georgia, United States, 31405
        • Not yet recruiting
        • CenExel iResearch, LLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60640
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Revive Research Institute, Inc.
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Not yet recruiting
        • Collective Medical Research
        • Contact:
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Center for Emotional Fitness
        • Contact:
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11235
        • Not yet recruiting
        • SPRI Clinical Trials, LLC
        • Contact:
      • Cedarhurst, New York, United States, 11516
        • Not yet recruiting
        • Neurobehavioral Research, Inc
        • Contact:
      • Mount Kisco, New York, United States, 10549
      • New York, New York, United States, 10128
      • Rochester, New York, United States, 14618
        • Withdrawn
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10329
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Not yet recruiting
        • Midwest Clinical Research Center
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Not yet recruiting
        • Lehigh Center for Clinical Research
        • Contact:
      • Media, Pennsylvania, United States, 19063
        • Not yet recruiting
        • Suburban Research Associates
        • Contact:
      • Moosic, Pennsylvania, United States, 18509
        • Not yet recruiting
        • Scranton Medical Institute
        • Contact:
    • South Carolina
    • Texas
      • Austin, Texas, United States, 78737
        • Not yet recruiting
        • Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
        • Contact:
      • Dallas, Texas, United States, 75234
        • Not yet recruiting
        • FutureSearch Trials of Dallas
        • Contact:
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • InSite Clinical Research, LLC
        • Contact:
      • Houston, Texas, United States, 77373
      • Plano, Texas, United States, 75093
      • Wichita Falls, Texas, United States, 76309
        • Not yet recruiting
        • Grayline Research Center
        • Contact:
    • Utah
      • Clinton, Utah, United States, 84015
        • Not yet recruiting
        • Alpine Reseach Organization
        • Contact:
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:

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

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
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
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

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 and 4 laboratory abnormalities.
Screening through Week 8

Collaborators and Investigators

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

Sponsor

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)

May 28, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 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 (Estimated)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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