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

Prior treatment

• Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.

Other illness

• Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
• Subjects with a history of medical conditions that may interfere with the conduct of the study.

Other

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

• Subjects experiencing a moderate to severe episode of depression.
• Subjects experiencing a current episode of depression for at least 2 months.
• Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
• Male and Female participants 18 to 75 years of age at the time of consent.
• Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.