Recruiting
Phase 2

Icalcaprant

Sponsor:

AbbVie

Code:

NCT07276997

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Icalcaprant

Placebo for Icalcaprant

Study Details

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.

Conditions

Major Depressive Disorder

Study ID

NCT07276997

Start date

Dec 18, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

195 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Icalcaprant Dose A

Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

experimental: Icalcaprant Dose B

Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

placebo comparator: Placebo for Icalcaprant

Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.

Interventions

Icalcaprant

Oral Capsules

Placebo for Icalcaprant

Oral Capsules

Primary outcome measure

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [ Time Frame: Up to approximately 6 weeks ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 10 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Harmonex /ID# 277517

Recruiting

Dothan, Alabama, United States, 36303

Ima Clinical Research Phoenix (Alea) /ID# 277516

Recruiting

Phoenix, Arizona, United States, 85012

Preferred Research Partners /ID# 279206

Recruiting

Little Rock, Arkansas, United States, 72211

Woodland International Research Group /ID# 277605

Recruiting

Little Rock, Arkansas, United States, 72211

Advanced Research Center /ID# 277537

Recruiting

Anaheim, California, United States, 92805

Sun Valley Research Center /ID# 277513

Recruiting

Imperial, California, United States, 92251

Synergy San Diego /ID# 277553

Recruiting

Lemon Grove, California, United States, 91945

Accellacare - Long Beach /ID# 279181

Recruiting

Long Beach, California, United States, 90807

CenExel CNR /ID# 277533

Recruiting

Sherman Oaks, California, United States, 91403

Inland Psychiatric Medical Group /ID# 279275

Recruiting

Temecula, California, United States, 92591

Sunwise Clinical Research /ID# 277555

Recruiting

Walnut Creek, California, United States, 94596

CenExel Hollywood FL /ID# 278200

Recruiting

Hollywood, Florida, United States, 33024

Cns Healthcare - Jacksonville /ID# 277658

Recruiting

Jacksonville, Florida, United States, 32256

GMI Florida - Central Miami Medical Institute /ID# 278218

Recruiting

Miami, Florida, United States, 33125

Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558

Recruiting

Orlando, Florida, United States, 32801

EquiPath Health & Research Tampa Bay, LLC /ID# 279128

Recruiting

Riverview, Florida, United States, 33578

Trialmed /ID# 277601

Recruiting

Atlanta, Georgia, United States, 30328

Evergreen Clinical Trials - Norcross /ID# 279421

Recruiting

Norcross, Georgia, United States, 30092

Flourish Research - Great Lakes Clinical Trials /ID# 278201

Recruiting

Chicago, Illinois, United States, 60640

Amr Conventions Research /ID# 277547

Recruiting

Warrenville, Illinois, United States, 60555

Redbird Research /ID# 277485

Recruiting

Las Vegas, Nevada, United States, 89119

Ima Clinical Research - Manhattan /ID# 278212

Recruiting

New York, New York, United States, 10036

Manhattan Behavioral Medicine /ID# 277910

Recruiting

New York, New York, United States, 10036

Quest Therapeutics of Avon /ID# 277550

Recruiting

Avon Lake, Ohio, United States, 44012-1004

OSU Psychiatry Department /ID# 277529

Recruiting

Columbus, Ohio, United States, 43210-1250

Sooner Clinical Research /ID# 277659

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Clinical Neuroscience Solutions /ID# 278192

Recruiting

Memphis, Tennessee, United States, 38119

Austin Clinical Trial Partners /ID# 279321

Recruiting

Austin, Texas, United States, 78737

Community Clinical Research - Cross Park Drive /ID# 277935

Recruiting

Austin, Texas, United States, 78754

Houston Clinical Trials - Bellaire /ID# 277551

Recruiting

Bellaire, Texas, United States, 77401

Pillar Clinical Research - Richardson /ID# 276764

Recruiting

Richardson, Texas, United States, 75080

Northwest Clinical Research Center /ID# 277484

Recruiting

Bellevue, Washington, United States, 98007

Core Clinical Research /ID# 277518

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

AbbVie

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Major Depressive Disorder
  • Icalcaprant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-15.