CompletedPhase 2

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

United States336 participantsStarted 2024-05-28

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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✓. 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.

✕. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
✕. 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.
✕. Females who are pregnant, breastfeeding or planning to become pregnant.

Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6

Timeframe: Baseline to Week 6

NCT IDNCT06419608

SponsorBiohaven Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-07