Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
- Registration Number
- NCT06419608
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Subjects experiencing a moderate to severe episode of depression.
- Subjects experiencing a current episode of depression for at least 2 months.
- Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
- Male and Female participants 18 to 75 years of age at the time of consent.
- Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
Key
- Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
- Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
- Subjects with a history of medical conditions that may interfere with the conduct of the study.
- Females who are pregnant, breastfeeding or planning to become pregnant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BHV-7000 BHV-7000 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 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).
- Secondary Outcome Measures
Name Time Method Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score 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.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6 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.
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1 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).
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1 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.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score 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).
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication 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
Number of Participants With Clinically Significant Laboratory Abnormalities 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.
Number of Participants With Vital Sign Abnormalities Screening through Week 8 Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation Screening through Week 8
Trial Locations
- Locations (65)
Reverie Mind, LLC
🇺🇸Chandler, Arizona, United States
IMA Clinical Research
🇺🇸Las Vegas, Nevada, United States
Pillar Clinical Research, LLC
🇺🇸Little Rock, Arkansas, United States
WIRG
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CIT LA
🇺🇸Bellflower, California, United States
IPMG
🇺🇸Chino, California, United States
WR-PRI Encino
🇺🇸Encino, California, United States
Collaborative Neuroscience Research, LLC (CenExel - CNS)
🇺🇸Garden Grove, California, United States
CalNeuro Research Group
🇺🇸Los Angeles, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
CIT IE
🇺🇸Riverside, California, United States
Lumos Clinical Research Center
🇺🇸San Jose, California, United States
Stanford
🇺🇸Stanford, California, United States
Cenexel CNS
🇺🇸Torrance, California, United States
Pacific Clinical Research Management Group
🇺🇸Upland, California, United States
Sunwise Clinical Research
🇺🇸Walnut Creek, California, United States
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
🇺🇸Norwich, Connecticut, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
Floridian Neuroscience Institute
🇺🇸Miami Lakes, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
K2 Medical Research
🇺🇸Tampa, Florida, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Revive Research Institute, Inc.
🇺🇸Elgin, Illinois, United States
Collective Medical Research
🇺🇸Overland Park, Kansas, United States
Delricht Research
🇺🇸New Orleans, Louisiana, United States
Headlands Pharmasite
🇺🇸Baltimore, Maryland, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Copley Clinical
🇺🇸Boston, Massachusetts, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Precise Clinical Research
🇺🇸Flowood, Mississippi, United States
Arch Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research, Inc
🇺🇸Cedarhurst, New York, United States
Bioscience Research LLC
🇺🇸Mount Kisco, New York, United States
Berman Clinical
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
RBA
🇺🇸Staten Island, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Summit Headlands LLC
🇺🇸Portland, Oregon, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Scranton Medical Institute
🇺🇸Moosic, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Relaro Medical Trials, LLC
🇺🇸Dallas, Texas, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Aim Trials
🇺🇸Plano, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Alpine Reseach Organization
🇺🇸Clinton, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States