Oral icalcaprant for adults with major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Harmonex /ID# 277517
  Dothan, Alabama, United States Recruiting
• Ima Clinical Research Phoenix (Alea) /ID# 277516
  Phoenix, Arizona, United States Recruiting
• Preferred Research Partners /ID# 279206
  Little Rock, Arkansas, United States Recruiting
• Woodland International Research Group /ID# 277605
  Little Rock, Arkansas, United States Recruiting
• Advanced Research Center /ID# 277537
  Anaheim, California, United States Recruiting
• Sun Valley Research Center /ID# 277513
  Imperial, California, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.