Psychiatry
PHASE2
● Phase II
Phase 2 Trial of Icalcaprant for MDD: Assessing Efficacy and Safety
ClinicalTrials.gov
Published March 27, 2026
AbbVie
NCT07276997 ↗
This Phase 2 study investigates the efficacy and safety of oral Icalcaprant in adults with major depressive disorder (MDD) who are experiencing a major depressive episode. The trial involves 195 participants across approximately 35 sites in North America. Participants are randomized into three treatment arms, with a 1 in 3 chance of receiving a placebo. The treatment period lasts for 6 weeks, followed by a 30-day safety follow-up. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, which will be used to assess the efficacy of Icalcaprant. Additionally, the number of participants experiencing adverse events will be recorded to evaluate safety. Secondary endpoints and detailed statistical outcomes are not yet available. The study design includes regular medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. The trial aims to provide insights into the potential of Icalcaprant as a treatment option for MDD, although the higher treatment burden compared to standard care is noted.
AI Accuracy Review: 9/10
· Auto-published
Imagine feeling trapped in a dark cloud, where sadness and fatigue overshadow every moment. This is the reality for many people with major depressive disorder, a condition that affects millions and can make even the simplest tasks feel overwhelming. Traditional treatments don’t work for everyone, leaving many searching for alternatives. Now, a new drug called Icalcaprant is being tested to see if it can help those currently experiencing a major depressive episode. In this study, about 195 adults will take either Icalcaprant or a placebo (a fake pill) daily for six weeks. Researchers will closely monitor their symptoms and any side effects. If Icalcaprant proves effective, it could provide a new lifeline for those who feel there’s no way out. However, it’s important to remember that not every treatment works for everyone, and the study is still in its early stages. As we wait for results, there’s hope that new options like Icalcaprant could make a real difference in the lives of those battling depression.
What this means for you: Icalcaprant may offer new hope for those struggling with severe depression symptoms.
View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Major Depressive Disorder
Intervention(s): Icalcaprant (DRUG), Placebo for Icalcaprant (DRUG)
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(s): Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.; Number of Participants with Adverse Events (AEs)
Enrollment: 195 (ESTIMATED)
Lead Sponsor: AbbVie
Start: 2025-12-18 | Primary Completion: 2027-09
