Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are to be rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of m

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
AbbVie

526 total trials

What NCT07276997 shows while recruiting

NCT07276997 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (48% lower).

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 names 20 study sites across 9 states, led by 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.

Learn More About Clinical Trials

Similar trials for Major Depressive Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07276997's enrollment target sits among peer trials

195 81st of 282 higher than 202 of 282 other Major Depressive Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04276922 · 195 participants · NA

    Creative Arts Program to Reduce Burnout in Healthcare Professionals

  • NCT04829357 · 195 participants

    Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

  • NCT05054738 · 195 participants · NA

    CRP and S&A for Inpatient Veterans

  • NCT05561595 · 195 participants · NA

    Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT07276997

Source: ClinicalTrials.gov NCT07276997, the US trial registry maintained by the National Library of Medicine. NCT07276997 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.