Icalcaprant for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with major depressive disorder currently in a depressive episode, lasting at least 4 weeks but not more than 6 months, can join this trial. They must have normal or non-significant abnormal physical exam results, lab tests, vital signs, and ECG readings. Their BMI should be between ≥18.0 to ≤35.0 kg/m2.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Icalcaprant
Trial Overview
The study is testing Icalcaprant's effect on depression symptoms compared to a placebo (a pill without the active drug). Participants will randomly receive either Icalcaprant or placebo capsules daily for six weeks and undergo regular medical assessments and questionnaires.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
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