Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
Purpose
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BHV-7000 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Reverie Mind, LLC
Chandler, Arizona 85226
Chandler, Arizona 85226
IMA Clinical Research
Phoenix, Arizona 85012
Phoenix, Arizona 85012
Pillar Clinical Research, LLC
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
Advanced Research Center, Inc.
Anaheim, California 92805
Anaheim, California 92805
IPMG
Chino, California 91710
Chino, California 91710
Collaborative Neuroscience Research, LLC (CenExel - CNS)
Garden Grove, California 92845
Garden Grove, California 92845
CalNeuro Research Group
Los Angeles, California 90025
Los Angeles, California 90025
Excell Research, Inc.
Oceanside, California 92056
Oceanside, California 92056
NRC Research Institute
Orange, California 92868
Orange, California 92868
Anderson Clinical Research
Redlands, California 92374
Redlands, California 92374
Lumos Clinical Research Center
San Jose, California 95124
San Jose, California 95124
Pacific Clinical Research Management Group
Upland, California 91786
Upland, California 91786
Sunwise Clinical Research
Walnut Creek, California 94596
Walnut Creek, California 94596
MCB Clinical Research Centers
Colorado Springs, Colorado 80910
Colorado Springs, Colorado 80910
Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
Norwich, Connecticut 06360
Norwich, Connecticut 06360
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Floridian Neuroscience Institute
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
Orlando, Florida 32801
K2 Medical Research
Tampa, Florida 33607
Tampa, Florida 33607
Neuroscience Research Institute
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
CenExel iResearch, LLC
Decatur, Georgia 30030
Decatur, Georgia 30030
CenExel iResearch, LLC
Savannah, Georgia 31405
Savannah, Georgia 31405
Uptown Research Institute
Chicago, Illinois 60640
Chicago, Illinois 60640
Revive Research Institute, Inc.
Elgin, Illinois 60123
Elgin, Illinois 60123
Collective Medical Research
Overland Park, Kansas 66210
Overland Park, Kansas 66210
Delricht Research
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Contact:
Caroline Campion
504-336-2667
Caroline Campion
504-336-2667
Headlands Pharmasite
Baltimore, Maryland 21208
Baltimore, Maryland 21208
CBH Health
Gaithersburg, Maryland 20877
Gaithersburg, Maryland 20877
Copley Clinical
Boston, Massachusetts 02116
Boston, Massachusetts 02116
Boston Clinical Trials
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Contact:
Joanne Monaghan
617-477-4868
Joanne Monaghan
617-477-4868
Adams Clinical
Watertown, Massachusetts 02472
Watertown, Massachusetts 02472
Precise Clinical Research
Flowood, Mississippi 39232
Flowood, Mississippi 39232
Arch Clinical Trials
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
IMA Clinical Research
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Bio Behavioral Health
Toms River, New Jersey 08755
Toms River, New Jersey 08755
SPRI Clinical Trials, LLC
Brooklyn, New York 11235
Brooklyn, New York 11235
Neurobehavioral Research, Inc
Cedarhurst, New York 11516
Cedarhurst, New York 11516
Berman Clinical
New York, New York 10029
New York, New York 10029
The Medical Research Network, LLC
New York, New York 10128
New York, New York 10128
Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
Allentown, Pennsylvania 18104
Suburban Research Associates
Media, Pennsylvania 19063
Media, Pennsylvania 19063
Scranton Medical Institute
Moosic, Pennsylvania 18509
Moosic, Pennsylvania 18509
Coastal Carolina Research Center
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
Austin, Texas 78737
Austin, Texas 78737
FutureSearch Trials of Dallas
Dallas, Texas 75234
Dallas, Texas 75234
Relaro Medical Trials, LLC
Dallas, Texas 75243
Dallas, Texas 75243
Contact:
Kali Gervais
469-730-3282
Kali Gervais
469-730-3282
Red Oak Psychiatry Associates, PA
Houston, Texas 77373
Houston, Texas 77373
Grayline Research Center
Wichita Falls, Texas 76309
Wichita Falls, Texas 76309
Alpine Reseach Organization
Clinton, Utah 84015
Clinton, Utah 84015
Northwest Clinical Research Center
Bellevue, Washington 98007
Bellevue, Washington 98007
More Details
- NCT ID
- NCT06419608
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.