ACTIVE_NOT_RECRUITING

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

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Conditions

Major Depressive Disorderdepressiondepresseddepressive disordermajor depressionmajor depressive episodeantidepressant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

Quick Facts

Study Start:2024-05-28
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06419608

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects experiencing a moderate to severe episode of depression.
  2. 2. Subjects experiencing a current episode of depression for at least 2 months.
  3. 3. Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
  4. 4. Male and Female participants 18 to 75 years of age at the time of consent.
  5. 5. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
  1. 1. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
  2. 2. Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
  3. 3. Subjects with a history of medical conditions that may interfere with the conduct of the study.
  4. 4. Females who are pregnant, breastfeeding or planning to become pregnant.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-05-28
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • depression
  • depressed
  • depressive disorder
  • major depression
  • major depressive episode
  • antidepressant

Additional Relevant MeSH Terms

  • Major Depressive Disorder