Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
195
Start Date
2025-12-18
Completion Date
2027-09
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Icalcaprant
Oral Capsules
Placebo for Icalcaprant
Oral Capsules
Locations (31)
Harmonex /ID# 277517
Dothan, Alabama, United States
Ima Clinical Research Phoenix (Alea) /ID# 277516
Phoenix, Arizona, United States
Preferred Research Partner, Inc /ID# 279206
Little Rock, Arkansas, United States
Woodland International Research Group /ID# 277605
Little Rock, Arkansas, United States
Advanced Research Center /ID# 277537
Anaheim, California, United States
Sun Valley Research Center /ID# 277513
Imperial, California, United States
Synergy San Diego /ID# 277553
Lemon Grove, California, United States
CenExel CNR /ID# 277533
Sherman Oaks, California, United States
Inland Psychiatric Medical Group Inc. /ID# 279275
Temecula, California, United States
Sunwise Clinical Research /ID# 277555
Walnut Creek, California, United States
CenExcel Clinical Research - Main Facility /ID# 278200
Hollywood, Florida, United States
Cns Healthcare - Jacksonville /ID# 277658
Jacksonville, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 278218
Miami, Florida, United States
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558
Orlando, Florida, United States
EquiPath Health & Research Tampa Bay, LLC /ID# 279128
Riverview, Florida, United States
Trialmed /ID# 277601
Atlanta, Georgia, United States
Flourish Research - Great Lakes Clinical Trials /ID# 278201
Chicago, Illinois, United States
Amr Conventions Research /ID# 277547
Warrenville, Illinois, United States
Redbird Research /ID# 277485
Las Vegas, Nevada, United States
Ima Clinical Research - Manhattan /ID# 278212
New York, New York, United States
Manhattan Behavioral Medicine /ID# 277910
New York, New York, United States
Quest Therapeutics of Avon /ID# 277550
Avon Lake, Ohio, United States
OSU Psychiatry Department /ID# 277529
Columbus, Ohio, United States
Sooner Clinical Research /ID# 277659
Oklahoma City, Oklahoma, United States
CNS Healthcare - Memphis /ID# 278192
Memphis, Tennessee, United States
Austin Clinical Trial Partners /ID# 279321
Austin, Texas, United States
Community Clinical Research - Austin - Cross Park Drive /ID# 277935
Austin, Texas, United States
Houston Clinical Trials - Bellaire /ID# 277551
Bellaire, Texas, United States
Pillar Clinical Research - Richardson /ID# 276764
Richardson, Texas, United States
Northwest Clinical Research Center /ID# 277484
Bellevue, Washington, United States
Core Clinical Research /ID# 277518
Everett, Washington, United States