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A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder

RecruitingPhase 2Ages 18 Years - 65 YearsAllAbbVie
NCT07276997 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with

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📋 Eligibility rules (as published)
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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What it tests

  • Icalcaprant
  • Placebo for Icalcaprant
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Where

33 sites
Harmonex /ID# 277517
Dothan, United States
Ima Clinical Research Phoenix (Alea) /ID# 277516
Phoenix, United States
Preferred Research Partners /ID# 279206
Little Rock, United States
Woodland International Research Group /ID# 277605
Little Rock, United States
Advanced Research Center /ID# 277537
Anaheim, United States
Sun Valley Research Center /ID# 277513
Imperial, United States
Synergy San Diego /ID# 277553
Lemon Grove, United States
Accellacare - Long Beach /ID# 279181
Long Beach, United States

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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