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NCT07276997 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Major Depressive Disorder, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
195
Enrollment target
20
Study locations

NCT07276997 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by AbbVie. The registered enrollment target is 195 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT07276997, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
195 participants
Enrollment target
20
Study locations

Study 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 Studied

Major Depressive Disorder

Interventions

  • DRUG Icalcaprant
  • DRUG Placebo for Icalcaprant

Study Locations (20)

California

  • Advanced Research Center /ID# 277537 - Anaheim
  • Sun Valley Research Center /ID# 277513 - Imperial
  • Synergy San Diego /ID# 277553 - Lemon Grove
  • CenExel CNR /ID# 277533 - Sherman Oaks
  • Inland Psychiatric Medical Group Inc. /ID# 279275 - Temecula
  • Sunwise Clinical Research /ID# 277555 - Walnut Creek

Florida

  • CenExcel Clinical Research - Main Facility /ID# 278200 - Hollywood
  • Cns Healthcare - Jacksonville /ID# 277658 - Jacksonville
  • GMI Florida - Central Miami Medical Institute /ID# 278218 - Miami
  • Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558 - Orlando
  • EquiPath Health & Research Tampa Bay, LLC /ID# 279128 - Riverview

Arkansas

  • Preferred Research Partner, Inc /ID# 279206 - Little Rock
  • Woodland International Research Group /ID# 277605 - Little Rock

Illinois

  • Flourish Research - Great Lakes Clinical Trials /ID# 278201 - Chicago
  • Amr Conventions Research /ID# 277547 - Warrenville

Alabama

  • Harmonex /ID# 277517 - Dothan

Arizona

  • Ima Clinical Research Phoenix (Alea) /ID# 277516 - Phoenix

Georgia

  • Trialmed /ID# 277601 - Atlanta

Nevada

  • Redbird Research /ID# 277485 - Las Vegas

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2025-12-18
Est. Completion 2027-09
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07276997

The ClinicalTrials.gov registry entry for NCT07276997 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (48% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Icalcaprant is the first listed.

NCT07276997 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT07276997 about?

NCT07276997 is a clinical study titled "A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder". 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, tir...

What is the current status of trial NCT07276997?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2025-12-18. Estimated completion is 2027-09.

What conditions does trial NCT07276997 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT07276997?

The interventions under investigation include: Icalcaprant (DRUG), Placebo for Icalcaprant (DRUG).

Who is sponsoring clinical trial NCT07276997?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07276997 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.