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A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
NCT07276997 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2025-12-18 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07276997 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07276997?
The interventions under investigation include: Icalcaprant (DRUG), Placebo for Icalcaprant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07276997?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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