A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants 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
1 other identifier
interventional
195
1 country
31
Brief Summary
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 major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Dec 2025
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedStudy Start
First participant enrolled
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 23, 2026
March 1, 2026
1.7 years
December 2, 2025
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Up to approximately 6 weeks
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 10 weeks
Secondary Outcomes (1)
Change from Baseline in Clinical Global Impression (CGIS)
Up to approximately 6 weeks
Study Arms (3)
Icalcaprant Dose A
EXPERIMENTALParticipants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Icalcaprant Dose B
EXPERIMENTALParticipants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Placebo for Icalcaprant
PLACEBO COMPARATORParticipants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (31)
Harmonex /ID# 277517
Dothan, Alabama, 36303, United States
Ima Clinical Research Phoenix (Alea) /ID# 277516
Phoenix, Arizona, 85012, United States
Preferred Research Partner, Inc /ID# 279206
Little Rock, Arkansas, 72211, United States
Woodland International Research Group /ID# 277605
Little Rock, Arkansas, 72211, United States
Advanced Research Center /ID# 277537
Anaheim, California, 92805, United States
Sun Valley Research Center /ID# 277513
Imperial, California, 92251, United States
Synergy San Diego /ID# 277553
Lemon Grove, California, 91945, United States
CenExel CNR /ID# 277533
Sherman Oaks, California, 91403, United States
Inland Psychiatric Medical Group Inc. /ID# 279275
Temecula, California, 92591, United States
Sunwise Clinical Research /ID# 277555
Walnut Creek, California, 94596, United States
CenExcel Clinical Research - Main Facility /ID# 278200
Hollywood, Florida, 33024, United States
Cns Healthcare - Jacksonville /ID# 277658
Jacksonville, Florida, 32256, United States
GMI Florida - Central Miami Medical Institute /ID# 278218
Miami, Florida, 33125, United States
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558
Orlando, Florida, 32801, United States
EquiPath Health & Research Tampa Bay, LLC /ID# 279128
Riverview, Florida, 33578, United States
Trialmed /ID# 277601
Atlanta, Georgia, 30328, United States
Flourish Research - Great Lakes Clinical Trials /ID# 278201
Chicago, Illinois, 60640, United States
Amr Conventions Research /ID# 277547
Warrenville, Illinois, 60555, United States
Redbird Research /ID# 277485
Las Vegas, Nevada, 89119, United States
Ima Clinical Research - Manhattan /ID# 278212
New York, New York, 10036, United States
Manhattan Behavioral Medicine /ID# 277910
New York, New York, 10036, United States
Quest Therapeutics of Avon /ID# 277550
Avon Lake, Ohio, 44012-1004, United States
OSU Psychiatry Department /ID# 277529
Columbus, Ohio, 43210-1250, United States
Sooner Clinical Research /ID# 277659
Oklahoma City, Oklahoma, 73116, United States
CNS Healthcare - Memphis /ID# 278192
Memphis, Tennessee, 38119, United States
Austin Clinical Trial Partners /ID# 279321
Austin, Texas, 78737, United States
Community Clinical Research - Austin - Cross Park Drive /ID# 277935
Austin, Texas, 78754, United States
Houston Clinical Trials - Bellaire /ID# 277551
Bellaire, Texas, 77401, United States
Pillar Clinical Research - Richardson /ID# 276764
Richardson, Texas, 75080, United States
Northwest Clinical Research Center /ID# 277484
Bellevue, Washington, 98007, United States
Core Clinical Research /ID# 277518
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 11, 2025
Study Start
December 18, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.