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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419608
• Other study ID #: BHV7000-305
• Status: Recruiting
• Phase: Phase 2
• Start date: May 28, 2024
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• BHV-7000
BHV-7000 75 mg taken once daily for 6 weeks
• Placebo
Matching placebo taken once daily for 6 weeks

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	CIT LA	Bellflower	California
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Neurobehavioral Research, Inc	Cedarhurst	New York
United States	Reverie Mind, LLC	Chandler	Arizona
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Uptown Research Institute	Chicago	Illinois
United States	Alpine Reseach Organization	Clinton	Utah
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	InSite Clinical Research, LLC	DeSoto	Texas
United States	Revive Research Institute, Inc.	Elgin	Illinois
United States	WR-PRI Encino	Encino	California
United States	UConn Health	Farmington	Connecticut
United States	Precise Clinical Research	Flowood	Mississippi
United States	CBH Health	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research, LLC (CenExel - CNS)	Garden Grove	California
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	IMA Clinical Research	Las Vegas	Nevada
United States	WIRG	Little Rock	Arkansas
United States	CalNeuro Research Group	Los Angeles	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	Floridian Neuroscience Institute	Miami Lakes	Florida
United States	Scranton Medical Institute	Moosic	Pennsylvania
United States	Bioscience Research LLC	Mount Kisco	New York
United States	The Medical Research Network, LLC	New York	New York
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Excell Research, Inc.	Oceanside	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Collective Medical Research	Overland Park	Kansas
United States	IMA Clinical Research	Phoenix	Arizona
United States	Aim Trials	Plano	Texas
United States	Anderson Clinical Research	Redlands	California
United States	CIT IE	Riverside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	WRN	Rogers	Arkansas
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	RBA	Staten Island	New York
United States	K2 Medical Research	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Cenexel CNS	Torrance	California
United States	Pacific Clinical Research Management Group	Upland	California
United States	Adams Clinical	Watertown	Massachusetts
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Therapeutics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from 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	Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score	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
Secondary	Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from 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
Secondary	Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from 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
Secondary	Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from 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
Secondary	Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score	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
Secondary	Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication	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
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities	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