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

BHV7000-305

The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)

2024-05-28

2025-05-01

2025-07-01

Recruiting

Early phase I

300

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2024-06-11