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

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 (othermedications 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 medicationstargeting insomnia) to treat depression at the screening visit.

2. Subjects with a history of bipolar disorder, schizophrenia, or otherneuropsychiatric conditions that may interfere with the conduct of the study.

3. Subjects with a history of medical conditions that may interfere with the conduct ofthe study.

4. Females who are pregnant, breastfeeding or planning to become pregnant.