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Oral icalcaprant for adults with major depressive disorder

A Phase 2, Multicenter, 6-Week, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Major Depressive Disorder

Phase 2 Interventional AbbVie · NCT07276997

This trial tests whether oral icalcaprant can reduce depressive symptoms and be tolerated by adults currently experiencing a major depressive episode.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment195 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAbbVie Industry-sponsored
Locations33 sites (Dothan, Alabama and 32 other locations)
Trial IDNCT07276997 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2 interventional trial will enroll about 195 adults with major depressive disorder and assign them to one of three treatment arms, with roughly a one-in-three chance of receiving placebo. Eligibility requires a DSM-5-TR diagnosis of MDD confirmed by the MINI and a current major depressive episode that began between 4 weeks and 6 months prior to screening. The study measures changes in disease activity and records adverse events while participants take oral icalcaprant or placebo across multiple clinic visits at approximately 35 sites in North America. Safety monitoring includes physical exams, laboratory tests, vital signs, and 12-lead ECGs documented at screening and during the study.

Who should consider this trial

Good fit: Adults with DSM-5-TR major depressive disorder who are currently in a major depressive episode (4 weeks to 6 months), have a BMI between 18 and 35 kg/m2, and meet the study's medical and ECG/lab criteria are the intended participants.

Not a fit: People with psychotic features, those who have failed three or more adequate antidepressant treatments during the current episode (treatment-resistant), or those with significant medical contraindications are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, icalcaprant could provide a new oral treatment option that reduces depressive symptoms with an acceptable safety profile.

How similar studies have performed: Some early-stage trials of kappa-opioid receptor antagonists and other novel mechanisms have shown promise, but icalcaprant's effectiveness for depression has not yet been proven in controlled studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Dothan, Alabama and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive DisorderIcalcaprant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.