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New depression pill shows promise in Long-Term safety check

NCT ID NCT06423781

Disease control Sponsor: Biohaven Therapeutics Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of a new daily medication called BHV-7000 for people with major depressive disorder. A total of 233 adults who had already completed an earlier study took the pill once a day. Researchers tracked side effects, lab results, and heart changes to see if the drug is safe to take over many months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BHV-7000 (a daily pill)
What this could lead to
If successful, this could point toward a new, long-term treatment option for major depressive disorder.
What could go wrong
This is an early-phase study focused only on safety, not on how well the drug works. The results may not lead to a proven treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

233 people

The number who actually took part.

Started

Aug 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Eligible subjects should have successfully completed the Treatment/Randomization Phase of parent studies. 2. WOCBP must have a negative urine pregnancy test at Baseline Visit. 3. WOCBP must not be breastfeeding or lactating at Baseline Visit or at any point during the study. Key Exclusion Criteria: 1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures. 2. Participant non-compliance with study procedures, study drug or visit attendance in the parent study that the Investigator deems as clinically significant or unacceptable risk potential for this study. 3. Investigator deems participant at imminent risk of danger to others.

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Conditions

The condition(s) this trial relates to.

Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Advanced Research Center, Inc.

    Anaheim, California, 92805, United States

  • Aim Trials

    Plano, Texas, 75093, United States

  • Alpine Reseach Organization

    Clinton, Utah, 84015, United States

  • Anderson Clinical Research

    Redlands, California, 92374, United States

  • Arch Clinical Trials

    St Louis, Missouri, 63141, United States

  • Berman Clinical

    New York, New York, 10029, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755, United States

  • Bioscience Research LLC

    Mount Kisco, New York, 10549, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CBH Health

    Gaithersburg, Maryland, 20877, United States

  • CIT IE

    Riverside, California, 92506, United States

  • CIT LA

    Bellflower, California, 90706, United States

  • CalNeuro Research Group

    Los Angeles, California, 90025, United States

  • CenExel iResearch, LLC

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405, United States

  • Cenexel CNS

    Torrance, California, 90504, United States

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Collaborative Neuroscience Research, LLC (CenExel - CNS)

    Garden Grove, California, 92845, United States

  • Collective Medical Research

    Overland Park, Kansas, 66210, United States

  • Copley Clinical

    Boston, Massachusetts, 02116, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners

    Austin, Texas, 78737, United States

  • Excell Research, Inc.

    Oceanside, California, 92056, United States

  • Floridian Neuroscience Institute

    Miami Lakes, Florida, 33016, United States

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75234, United States

  • Grayline Research Center

    Wichita Falls, Texas, 76309, United States

  • Headlands Pharmasite

    Baltimore, Maryland, 21208, United States

  • IMA Clinical Research

    Phoenix, Arizona, 85012, United States

  • IMA Clinical Research

    Las Vegas, Nevada, 89102, United States

  • IPMG

    Chino, California, 91710, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115, United States

  • K2 Medical Research

    Tampa, Florida, 33607, United States

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • Lumos Clinical Research Center, LLC

    San Jose, California, 95124, United States

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • NRC Research Institute

    Orange, California, 92868, United States

  • Neurobehavioral Research, Inc

    Cedarhurst, New York, 11516, United States

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut

    Norwich, Connecticut, 06360, United States

  • Pacific Clinical Research Management Group

    Upland, California, 91786, United States

  • Pillar Clinical Research, LLC

    Little Rock, Arkansas, 72204, United States

  • Precise Clinical Research

    Flowood, Mississippi, 39232, United States

  • RBA

    Staten Island, New York, 10329, United States

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77373, United States

  • Relaro Medical Trials, LLC

    Dallas, Texas, 75243, United States

  • Reverie Mind, LLC

    Chandler, Arizona, 85226, United States

  • Revive Research Institute, Inc.

    Elgin, Illinois, 60123, United States

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235, United States

  • Scranton Medical Institute

    Moosic, Pennsylvania, 18509, United States

  • Stanford

    Stanford, California, 94305, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Summit Headlands LLC

    Portland, Oregon, 97210, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • The Medical Research Network, LLC

    New York, New York, 10128, United States

  • UConn Health

    Farmington, Connecticut, 06030, United States

  • Uptown Research Institute

    Chicago, Illinois, 60640, United States

  • WIRG

    Little Rock, Arkansas, 72211, United States

  • WR-PRI Encino

    Encino, California, 91316, United States

  • WRN

    Rogers, Arkansas, 72758, United States

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