A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression
1 other identifier
interventional
195
1 country
29
Brief Summary
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. This study will assess how safe and effective Icalcaprant is in treating adult participants with bipolar I or II disorder. Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II 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 a placebo. Around 195 adult participants with bipolar I or II disorder will be enrolled in approximately 35 sites across the United States of America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedStudy Start
First participant enrolled
February 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
April 14, 2026
April 1, 2026
1.7 years
November 18, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
Up to approximately Week 6
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study
Up to approximately 10 weeks
Secondary Outcomes (1)
Change from Baseline to Week 6 in Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) score
Up to approximately Week 6
Study Arms (3)
Group 1: Icalcaprant Dose A
EXPERIMENTALParticipants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.
Group 2: Icalcaprant Dose B
EXPERIMENTALParticipants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.
Group 3: Placebo for Icalcaprant
PLACEBO COMPARATORParticipants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.
Interventions
Oral Capsules
Eligibility Criteria
You may qualify if:
- Participants with a diagnosis of bipolar I or II according to the (Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0.2, and currently experiencing an (major depressive episode) MDE beginning at least 4 weeks prior to consent and not exceeding 6 months prior to screening.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
- CGI-S-BP score of ≥ 4 for depression and overall bipolar illness at screening (Visit 1) and baseline (Visit 2).
- YMRS total score ≤ 12 at screening (Visit 1) and baseline (Visit 2).
- Participants on treatment with a single mood stabilizer (lithium, valproate, or lamotrigine), maintained at a stable dose for ≥ 28 days prior to screening. Current mood stabilizer dose must remain unchanged for the duration of the study.
- If taking lithium or valproate, participant must have a therapeutic blood level at screening of lithium (0.8 - 1.2 mg/dL) or valproate (50 - 125 mg/dL).
- If taking lamotrigine, participant must be taking a locally approved maintenance dose.
You may not qualify if:
- 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.
- History of or active medical conditions(s) that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included in the study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (29)
University of Alabama - Huntsville Regional Medical Campus /ID# 272951
Huntsville, Alabama, 35801, United States
Chandler Clinical Research Trials /ID# 274500
Chandler, Arizona, 85224, United States
Sanro Clinical Research Group /ID# 279462
Bryant, Arkansas, 72022, United States
Advanced Research Center /ID# 272828
Anaheim, California, 92805, United States
Collaborative Neuroscience Research - Garden Grove /ID# 271917
Garden Grove, California, 92845, United States
Catalina Research Institute, LLC /ID# 272831
Montclair, California, 91763, United States
Excell Research /ID# 272854
Oceanside, California, 92056, United States
Pacific Neuropsychiatric Specialists - Orange /ID# 273118
Orange, California, 92868, United States
Schuster Medical Research Institute /ID# 272848
Sherman Oaks, California, 91403, United States
CenExel Hollywood FL /ID# 273101
Hollywood, Florida, 33024, United States
Accel Research Sites Network - St. Pete /ID# 272962
Largo, Florida, 33777, United States
Apg Research /ID# 272925
Orlando, Florida, 32803, United States
Combined Research Orlando Phase I-IV /ID# 279458
Orlando, Florida, 32814, United States
Clinical Research Center Of Florida /ID# 278790
Pompano Beach, Florida, 33060, United States
Neuroscience Institute - West Palm Beach /ID# 272922
West Palm Beach, Florida, 33407, United States
Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 279438
Atlanta, Georgia, 30318, United States
Pillar Clinical Research - Chicago /ID# 272823
Chicago, Illinois, 60641, United States
Amr Conventions Research /ID# 272867
Warrenville, Illinois, 60555, United States
St. Charles Psychiatric Associates /ID# 279239
Saint Charles, Missouri, 63304, United States
Manhattan Behavioral Medicine /ID# 279769
New York, New York, 10036, United States
University Of Cincinnati Medical Center /ID# 274160
Cincinnati, Ohio, 45219, United States
The Ohio State University /ID# 272954
Columbus, Ohio, 43210, United States
Sooner Clinical Research /ID# 272856
Oklahoma City, Oklahoma, 73116, United States
Community Clinical Research - Austin - Cross Park Drive /ID# 272940
Austin, Texas, 78754, United States
Elixia - Houston /ID# 279200
Houston, Texas, 77007, United States
Pillar Clinical Research - Richardson /ID# 272821
Richardson, Texas, 75080, United States
Family Psychiatry Of The Woodlands /ID# 275177
The Woodlands, Texas, 77381, United States
Northwest Clinical Research Center /ID# 272847
Bellevue, Washington, 98007, United States
Core Clinical Research /ID# 272955
Everett, Washington, 98201, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 20, 2024
Study Start
February 3, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.