RECRUITING

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

Description

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

Conditions

Major Depressive Disorder
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Related Conditions:

Major Depressive Disorder

Study Overview

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Study Details

Study overview

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

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Chandler

Reverie Mind, LLC, Chandler, Arizona, United States, 85226

Phoenix

IMA Clinical Research, Phoenix, Arizona, United States, 85012

Little Rock

WIRG, Little Rock, Arkansas, United States, 72211

Rogers

WRN, Rogers, Arkansas, United States, 72758

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805

Bellflower

CIT LA, Bellflower, California, United States, 90706

Encino

WR-PRI Encino, Encino, California, United States, 91316

Garden Grove

Collaborative Neuroscience Research, LLC (CenExel - CNS), Garden Grove, California, United States, 92845

Los Angeles

CalNeuro Research Group, Los Angeles, California, United States, 90025

Oceanside

Excell Research, Inc., Oceanside, California, United States, 92056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biohaven Therapeutics Ltd.,

Study Record Dates

2025-07