A Phase 2 interventional study of BHV-7000 and Placebo in Major Depressive Disorder, sponsored by Biohaven Therapeutics Ltd.. Completed at 62 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Biohaven Therapeutics Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's enrollment of 336 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Biohaven Therapeutics Ltd. is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: BHV-7000
Drug: Placebo
BHV-7000 75 mg taken once daily for 6 weeks
Matching placebo taken once daily for 6 weeks
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).
Time frame: Baseline to Week 6
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.
Time frame: Baseline to Week 6
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.
Time frame: Baseline to Week 6
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).
Time frame: Baseline to Week 1
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.
Time frame: Baseline to Week 1
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).
Time frame: Baseline to Week 6
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
Time frame: Screening through Week 8
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 or 4 laboratory abnormalities.
Time frame: Screening through Week 8
Number of Participants With Vital Sign Abnormalities
Time frame: Screening through Week 8
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time frame: Screening through Week 8
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Biohaven Therapeutics Ltd.