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New depression pill icalcaprant enters Mid-Stage trial

NCT ID NCT07276997

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug, icalcaprant, for adults with major depressive disorder who are currently having a depressive episode. About 195 participants will take either the drug or a placebo daily for 6 weeks. Researchers will measure changes in depression symptoms and watch for side effects.

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

About 195 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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 65 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.

Inclusion Criteria: * Participants with a diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2 * Currently experiencing an major depressive episode (MDE) beginning at least 4 weeks prior to consent and not exceeding 6 months prior to Screening * Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at Visit 1 or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF. Exclusion Criteria: * Has failed (no more than 25% response on Antidepressant Treatment History Questionnaire (ATRQ)) 3 or more antidepressant treatments during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks). * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accellacare - Long Beach /ID# 279181

    RECRUITING

    Long Beach, California, 90807, United States

  • Advanced Research Center /ID# 277537

    RECRUITING

    Anaheim, California, 92805, United States

  • Amr Conventions Research /ID# 277547

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Austin Clinical Trial Partners /ID# 279321

    RECRUITING

    Austin, Texas, 78737, United States

  • CenExel CNR /ID# 277533

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • CenExel Hollywood FL /ID# 278200

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions /ID# 278192

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Cns Healthcare - Jacksonville /ID# 277658

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Community Clinical Research - Cross Park Drive /ID# 277935

    RECRUITING

    Austin, Texas, 78754, United States

  • Core Clinical Research /ID# 277518

    RECRUITING

    Everett, Washington, 98201, United States

  • EquiPath Health & Research Tampa Bay, LLC /ID# 279128

    RECRUITING

    Riverview, Florida, 33578, United States

  • Evergreen Clinical Trials - Norcross /ID# 279421

    RECRUITING

    Norcross, Georgia, 30092, United States

  • Flourish Research - Great Lakes Clinical Trials /ID# 278201

    RECRUITING

    Chicago, Illinois, 60640, United States

  • GMI Florida - Central Miami Medical Institute /ID# 278218

    RECRUITING

    Miami, Florida, 33125, United States

  • Harmonex /ID# 277517

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Houston Clinical Trials - Bellaire /ID# 277551

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Ima Clinical Research - Manhattan /ID# 278212

    RECRUITING

    New York, New York, 10036, United States

  • Ima Clinical Research Phoenix (Alea) /ID# 277516

    RECRUITING

    Phoenix, Arizona, 85012, United States

  • Inland Psychiatric Medical Group /ID# 279275

    RECRUITING

    Temecula, California, 92591, United States

  • Manhattan Behavioral Medicine /ID# 277910

    RECRUITING

    New York, New York, 10036, United States

  • Northwest Clinical Research Center /ID# 277484

    RECRUITING

    Bellevue, Washington, 98007, United States

  • OSU Psychiatry Department /ID# 277529

    RECRUITING

    Columbus, Ohio, 43210-1250, United States

  • Pillar Clinical Research - Richardson /ID# 276764

    RECRUITING

    Richardson, Texas, 75080, United States

  • Preferred Research Partners /ID# 279206

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Quest Therapeutics of Avon /ID# 277550

    RECRUITING

    Avon Lake, Ohio, 44012-1004, United States

  • Redbird Research /ID# 277485

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Sooner Clinical Research /ID# 277659

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Sun Valley Research Center /ID# 277513

    RECRUITING

    Imperial, California, 92251, United States

  • Sunwise Clinical Research /ID# 277555

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Synergy San Diego /ID# 277553

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Trialmed /ID# 277601

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Woodland International Research Group /ID# 277605

    RECRUITING

    Little Rock, Arkansas, 72211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.