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

Biohaven

Status and phase: Enrolling; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: BHV-7000; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419608

BHV7000-305

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

BHV-7000

Experimental group

Treatment:

Drug: BHV-7000

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo