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Testing BHV-7000 for treating major depression

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

PHASE2 · Biohaven Pharmaceuticals, Inc. · NCT06419608

This study is testing a new treatment called BHV-7000 to see if it can help adults with major depression feel better compared to a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBiohaven Pharmaceuticals, Inc. (industry)
Locations67 sites (Chandler, Arizona and 66 other locations)
Trial IDNCT06419608 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of BHV-7000, a new treatment, in individuals diagnosed with Major Depressive Disorder (MDD). Participants will be monitored for their response to the treatment compared to a placebo over a specified period. The study will include adults aged 18 to 75 who are experiencing a moderate to severe depressive episode lasting at least two months. Participants will need to stop any current psychotropic medications before joining the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with moderate to severe major depressive episodes lasting at least two months.

Not a fit: Patients with bipolar disorder, schizophrenia, or those currently on multiple depression medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from major depression.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of BHV-7000 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chandler, Arizona and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Major Depressive Disorder, depression, depressed, depressive disorder, major depression, major depressive episode, antidepressant

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.