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

Phase 2

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: BHV-7000; Drug: Placebo

• 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

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Study Start: 2024-05-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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

Scroll for more (55 remaining)