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Study identifier: NCT07276997 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Major Depressive Disorder  ·  Sponsor: AbbVie

PhasePhase 2
Planned participants195
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (33)

Harmonex /ID# 277517Dothan, Alabama, United StatesRecruiting
Ima Clinical Research Phoenix (Alea) /ID# 277516Phoenix, Arizona, United StatesRecruiting
Preferred Research Partners /ID# 279206Little Rock, Arkansas, United StatesRecruiting
Woodland International Research Group /ID# 277605Little Rock, Arkansas, United StatesRecruiting
Advanced Research Center /ID# 277537Anaheim, California, United StatesRecruiting
Sun Valley Research Center /ID# 277513Imperial, California, United StatesRecruiting
Synergy San Diego /ID# 277553Lemon Grove, California, United StatesRecruiting
Accellacare - Long Beach /ID# 279181Long Beach, California, United StatesRecruiting
CenExel CNR /ID# 277533Sherman Oaks, California, United StatesRecruiting
Inland Psychiatric Medical Group /ID# 279275Temecula, California, United StatesRecruiting
Sunwise Clinical Research /ID# 277555Walnut Creek, California, United StatesRecruiting
CenExel Hollywood FL /ID# 278200Hollywood, Florida, United StatesRecruiting

+ 21 more locations — full list on the registry record.

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