Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression

ID#: NCT06419608

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: May 28, 2024

End Date: July 01, 2025

Contact Information:
Chief Medical Officer
203-404-0410
Summary: The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
Eligibility: 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.
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