Clinical trial NCT06419608: Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: depression
depressed
depressive disorder
major depression
major depressive episode
antidepressant
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
timeFrame: Baseline to Week 6
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6
timeFrame: Baseline to Week 6
measure: Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1
timeFrame: Baseline to Week 1
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1
timeFrame: Baseline to Week 1
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score
timeFrame: Baseline to Week 6
measure: Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
timeFrame: Screening through Week 8
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Screening through Week 8
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Screening through Week 8
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
timeFrame: Screening through Week 8
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Reverie Mind, LLC
state: Arizona
city: Phoenix
country: United States
facility: IMA Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Pillar Clinical Research, LLC
state: Arkansas
city: Little Rock
country: United States
facility: WIRG
state: Arkansas
city: Rogers
country: United States
facility: WRN
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: CIT LA
state: California
city: Chino
country: United States
facility: IPMG
state: California
city: Encino
country: United States
facility: WR-PRI Encino
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC (CenExel - CNS)
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Riverside
country: United States
facility: CIT IE
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: Torrance
country: United States
facility: Cenexel CNS
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Norwich
country: United States
facility: Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Neuroscience Institute
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Neuroscience Research Institute
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Baltimore
country: United States
facility: Headlands Pharmasite
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: Flowood
country: United States
facility: Precise Clinical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Arch Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: IMA Clinical Research
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: New York
country: United States
facility: Berman Clinical
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: RBA
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Summit Headlands LLC
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Moosic
country: United States
facility: Scranton Medical Institute
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials, LLC
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Plano
country: United States
facility: Aim Trials
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Clinton
country: United States
facility: Alpine Reseach Organization
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
References: