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BHV-7000 for Depression

Verified Trial
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
Have you been diagnosed with Major Depressive Disorder?
Have you been experiencing symptoms of depression for over 2 months but less than 2 years?
Must not have
Have you participated in more than one clinical research studies in the past 5 years where you received a medication?
Have you ever been diagnosed with any of the following? Bipolar disorder, Schizophrenia or schizoaffective disorder, Borderline or narcissistic personality disorder, Dementia or Alzheimer’s, Parkinson’s, Autism, Seizure disorder, Traumatic brain injury, OCD, Anorexia or bulimia, Alcohol or substance use disorder or alcohol addiction in the last six months, High blood pressure or diabetes, Cancer in the past 5 years, Major surgery or blood transfusion in the past month, ADHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through week 8

Summary

This trial is testing a new medication called BHV-7000 to see if it helps people with severe depression and if it is safe.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
Secondary study objectives
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
11 Previous Clinical Trials
4,396 Total Patients Enrolled
1 Trials studying Depression
480 Patients Enrolled for Depression
~109 spots leftby May 2025
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