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BHV-7000 for Depression

Phase 2
Recruiting
Research Sponsored by Biohaven Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects experiencing a moderate to severe episode of depression
Subjects must be willing to discontinue all psychotropic medications before entering the study
Must not have
Subjects taking more than 2 medications to treat depression at the screening visit (excluding benzodiazepines and medications targeting insomnia)
Females who are pregnant, breastfeeding or planning to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through week 8
Awards & highlights

Summary

"This trial aims to see if BHV-7000 is effective and safe for people with Major Depressive Disorder."

Who is the study for?
This trial is for adults aged 18-75 with moderate to severe depression lasting at least 2 months. Participants must have a BMI between 18 and 35, agree to stop all psychotropic meds before the study, and not be pregnant or planning pregnancy. Those with bipolar disorder, schizophrenia, or on multiple depression medications are excluded.
What is being tested?
The trial is testing BHV-7000's effectiveness and safety in treating Major Depressive Disorder (MDD). Participants will either receive BHV-7000 or a placebo to compare outcomes.
What are the potential side effects?
While specific side effects of BHV-7000 aren't listed here, common antidepressant side effects include nausea, sleep disturbances, fatigue, dry mouth, blurred vision, constipation, weight gain or loss and sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing a moderate to severe episode of depression.
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I am willing to stop taking all my psychiatric medications for the study.
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I have been feeling depressed for at least 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking more than 2 medications for depression.
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I am not pregnant, breastfeeding, nor planning to become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
Secondary outcome measures
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV-7000Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Biohaven Therapeutics Ltd.Lead Sponsor
10 Previous Clinical Trials
3,852 Total Patients Enrolled
1 Trials studying Depression
480 Patients Enrolled for Depression
~191 spots leftby May 2025
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