Major Depressive Disorder Study

Major Depressive Disorder
A Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder

Do you or someone you love suffer from Major Depresssive Disorder (MDD)?

We are conducting a clinical trial to determine whether BHV-7000 is a safe and effective treatment for major depressive disorder.

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Enrolling Patients
NCT06419608
Phase 2
50 Study Locations
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Length of Study

Up To 12 Weeks
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# Study Visits

7
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Post-study Follow Up

2 Weeks
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Who’s Included?

Adults

18–75
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Drug & Formulation

BHV-7000

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Possibility of Placebo

Yes

What is Major Despressive Disorder (MDD)?

Major Depressive Disorder (MDD) is a persistent mental health condition characterized by recurrent episodes of profound sadness, loss of interest or pleasure, changes in appetite or weight, sleep disturbances, fatigue, feelings of worthlessness or guilt, and difficulty concentrating or making decisions.

These episodes, commonly referred to as ‘depressive episodes’, significantly impact a person’s ability to function in daily life and can last for weeks or months. Despite the availability of numerous treatment options, including various antidepressant medications and psychotherapy, many individuals with MDD struggle to find relief from their symptoms. Moreover, some individuals experience intolerable side effects from medications, which can exacerbate the burden of the disorder.

  • Participants Must:

  • Be experiencing a moderate to severe episode of depression.
  • Be experiencing a current episode of depression for at least 2 months.
  • Be willing to discontinue all psychotropic medications (eg other medications used to treat depression) before entering the study.
  • Be between the ages of 18 to 75.
  • Be between a Body Mass Index (BMI) of 18 and 35 kg/m2.
  • Participants Must Not:

  • Be taking more than 2 medications (other than benzodiazepines) to treat depression at the screening visit.
  • Have a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of this study.
  • Have a history of medical conditions that may interfere with the conduct of this study.
  • Females who are pregnant, breastfeeding, or planning to become pregnant.

Frequently Asked Questions

About 300 people will participate in this study.

The study is being conducted by Biohaven.

The study lasts up to 12 weeks (4 weeks screening, 6 weeks outpatient treatment, 2 weeks safety follow up).

There is the potential for participants who complete the double-blind study to participate in a 52-week open-label extension study.

After the 6-week treatment phase of the study, subjects may be eligible to transfer into an ‘open-label’ study during which all subjects will receive the active drug for up to one year. If a subject is not eligible to transfer to the ‘open-label’ study or chooses not to transfer, they will have a safety follow-up visit two weeks after their last visit of the ‘randomized’ phase of the study.

Visit the See If You Qualify page and fill out the form. A clinician will then contact you to discuss your qualifications.

Learn more about the benefits of joining our trial and see if you qualify today!