A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
NCT ID: NCT07276997
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
195 participants
INTERVENTIONAL
2025-12-18
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Icalcaprant Dose A
Participants will receive oral Icalcaprant dose A once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Icalcaprant
Oral Capsules
Icalcaprant Dose B
Participants will receive oral Icalcaprant dose B once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Icalcaprant
Oral Capsules
Placebo for Icalcaprant
Participants will receive oral placebo once daily for 6 weeks and attend a follow up visit 30 days following end of treatment.
Placebo for Icalcaprant
Oral Capsules
Interventions
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Icalcaprant
Oral Capsules
Placebo for Icalcaprant
Oral Capsules
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2
* Currently experiencing an major depressive episode (MDE) beginning at least 4 weeks prior to consent and not exceeding 6 months prior to Screening
* Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at Visit 1 or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF.
Exclusion Criteria
* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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CenExel CNR /ID# 277533
Sherman Oaks, California, United States
Viking Clinical Research Center - Temecula /ID# 279275
Temecula, California, United States
Sunwise Clinical Research /ID# 277555
Walnut Creek, California, United States
CenExcel Clinical Research - Main Facility /ID# 278200
Hollywood, Florida, United States
Cns Healthcare - Jacksonville /ID# 277658
Jacksonville, Florida, United States
GMI Florida - Central Miami Medical Institute /ID# 278218
Miami, Florida, United States
Clinical Neuroscience Solutions - Orlando - East South Street /ID# 277558
Orlando, Florida, United States
Trialmed /ID# 277601
Atlanta, Georgia, United States
Amr Conventions Research /ID# 277547
Warrenville, Illinois, United States
Manhattan Behavioral Medicine /ID# 277910
New York, New York, United States
Sooner Clinical Research /ID# 277659
Oklahoma City, Oklahoma, United States
CNS Healthcare - Memphis /ID# 278192
Memphis, Tennessee, United States
Northwest Clinical Research Center /ID# 277484
Bellevue, Washington, United States
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M25-987
Identifier Type: -
Identifier Source: org_study_id
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