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The trial is taking place at:
A

Adams Clinical | Watertown, MA

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

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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

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

Trial contacts and locations

50

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Central trial contact

Chief Medical Officer

Data sourced from clinicaltrials.gov

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