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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07276997

Public ClinicalTrials.gov record NCT07276997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 12:21 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07276997
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
AbbVie
Industry
Enrollment
195 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 17, 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027
Last update posted
Jun 14, 2026

2025 – 2027

United States locations

U.S. sites
33
U.S. states
14
U.S. cities
30
Facility City State ZIP Site status
Harmonex /ID# 277517 Dothan Alabama 36303 Recruiting
Ima Clinical Research Phoenix (Alea) /ID# 277516 Phoenix Arizona 85012 Recruiting
Preferred Research Partners /ID# 279206 Little Rock Arkansas 72211 Recruiting
Woodland International Research Group /ID# 277605 Little Rock Arkansas 72211 Recruiting
Advanced Research Center /ID# 277537 Anaheim California 92805 Recruiting
Sun Valley Research Center /ID# 277513 Imperial California 92251 Recruiting
Synergy San Diego /ID# 277553 Lemon Grove California 91945 Recruiting
Accellacare - Long Beach /ID# 279181 Long Beach California 90807 Recruiting
CenExel CNR /ID# 277533 Sherman Oaks California 91403 Recruiting
Inland Psychiatric Medical Group /ID# 279275 Temecula California 92591 Recruiting
Sunwise Clinical Research /ID# 277555 Walnut Creek California 94596 Recruiting
CenExel Hollywood FL /ID# 278200 Hollywood Florida 33024 Recruiting
Cns Healthcare - Jacksonville /ID# 277658 Jacksonville Florida 32256 Recruiting
GMI Florida - Central Miami Medical Institute /ID# 278218 Miami Florida 33125 Recruiting
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558 Orlando Florida 32801 Recruiting
EquiPath Health & Research Tampa Bay, LLC /ID# 279128 Riverview Florida 33578 Recruiting
Trialmed /ID# 277601 Atlanta Georgia 30328 Recruiting
Evergreen Clinical Trials - Norcross /ID# 279421 Norcross Georgia 30092 Recruiting
Flourish Research - Great Lakes Clinical Trials /ID# 278201 Chicago Illinois 60640 Recruiting
Amr Conventions Research /ID# 277547 Warrenville Illinois 60555 Recruiting
Redbird Research /ID# 277485 Las Vegas Nevada 89119 Recruiting
Ima Clinical Research - Manhattan /ID# 278212 New York New York 10036 Recruiting
Manhattan Behavioral Medicine /ID# 277910 New York New York 10036 Recruiting
Quest Therapeutics of Avon /ID# 277550 Avon Lake Ohio 44012-1004 Recruiting
OSU Psychiatry Department /ID# 277529 Columbus Ohio 43210-1250 Recruiting
Sooner Clinical Research /ID# 277659 Oklahoma City Oklahoma 73116 Recruiting
Clinical Neuroscience Solutions /ID# 278192 Memphis Tennessee 38119 Recruiting
Austin Clinical Trial Partners /ID# 279321 Austin Texas 78737 Recruiting
Community Clinical Research - Cross Park Drive /ID# 277935 Austin Texas 78754 Recruiting
Houston Clinical Trials - Bellaire /ID# 277551 Bellaire Texas 77401 Recruiting
Pillar Clinical Research - Richardson /ID# 276764 Richardson Texas 75080 Recruiting
Northwest Clinical Research Center /ID# 277484 Bellevue Washington 98007 Recruiting
Core Clinical Research /ID# 277518 Everett Washington 98201 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07276997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2026 · Synced Sep 10, 2026

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