Actively Recruiting
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Oral Icalcaprant in Adults With Bipolar I or II Disorder
Led by AbbVie · Updated on 2026-05-13
195
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Icalcaprant, an investigational oral drug, in treating adults with bipolar I or II disorder who are experiencing depressive episodes. The study focuses on adult participants diagnosed according to DSM-5-TR criteria, aiming to measure changes in depression severity and adverse events during treatment. This phase 2 trial involves approximately 195 adults across about 35 sites in the United States. Participants are randomly assigned to one of three groups: two different doses of Icalcaprant or a placebo. Each participant takes oral capsules once daily for 6 weeks, followed by a 4-week safety follow-up period. The study includes regular visits to a hospital or clinic for treatment administration and monitoring. During participation, individuals will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers will evaluate changes from baseline to week 6 using the Montgomery-Åsberg Depression Rating Scale (MADRS) and track adverse events up to about 10 weeks. The study also includes assessments of bipolar disorder severity, and participants will be followed for safety four weeks after treatment ends.
CONDITIONS
Brief Title
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosis of bipolar I or II disorder without psychotic features confirmed by MINI 7.0.2
- Currently experiencing a major depressive episode lasting at least 4 weeks and no more than 6 months before screening
- Body mass index between 18.0 and 35.0 kg/m²
- General good health based on medical history, physical exam, vital signs, lab tests, and ECG
- Clinical Global Impression of Severity for Bipolar Disorder score of 4 or higher for depression at screening and baseline
- Young Mania Rating Scale total score of 12 or less at screening and baseline
- On a stable dose of a single mood stabilizer (lithium, valproate, or lamotrigine) for at least 28 days prior to screening
- Therapeutic blood levels required for lithium or valproate users at screening
- Maintenance dose according to local approval for lamotrigine users
You will not qualify if you...
- History of allergic reaction or significant sensitivity to the study drug or similar products
- History or active unstable medical conditions that may interfere with study conduct or participant safety
- History or evidence of malignancy except treated basal or squamous cell carcinoma
- Significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorders unless stable for over 1 year and not requiring prohibited treatments
- Conditions judged by the investigator to interfere with study participation or interpretation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive oral Icalcaprant or placebo once daily for 6 weeks.
Weekly visits for up to 6 weeks
Duration - 4 weeks
Participants are followed for safety and disease activity assessments after treatment ends.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 31 locations
1
University of Alabama - Huntsville Regional Medical Campus /ID# 272951
Huntsville, Alabama, United States, 35801
Actively Recruiting
2
Chandler Clinical Research Trials /ID# 274500
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Sanro Clinical Research Group /ID# 279462
Bryant, Arkansas, United States, 72022
Actively Recruiting
4
Advanced Research Center /ID# 272828
Anaheim, California, United States, 92805
Actively Recruiting
5
Collaborative Neuroscience Research - Garden Grove /ID# 271917
Garden Grove, California, United States, 92845
Actively Recruiting
6
Catalina Research Institute, LLC /ID# 272831
Montclair, California, United States, 91763
Actively Recruiting
7
Excell Research /ID# 272854
Oceanside, California, United States, 92056
Actively Recruiting
8
Pacific Neuropsychiatric Specialists - Orange /ID# 273118
Orange, California, United States, 92868
Actively Recruiting
9
Schuster Medical Research Institute /ID# 272848
Sherman Oaks, California, United States, 91403
Actively Recruiting
10
CenExel Hollywood FL /ID# 273101
Hollywood, Florida, United States, 33024
Actively Recruiting
11
Accel Research Sites Network - St. Pete /ID# 272962
Largo, Florida, United States, 33777
Actively Recruiting
12
Apg Research /ID# 272925
Orlando, Florida, United States, 32803
Actively Recruiting
13
Combined Research Orlando Phase I-IV /ID# 279458
Orlando, Florida, United States, 32814
Actively Recruiting
14
Clinical Research Center Of Florida /ID# 278790
Pompano Beach, Florida, United States, 33060
Actively Recruiting
15
St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465
Saint Augustine, Florida, United States, 32086
Actively Recruiting
16
Neuroscience Institute - West Palm Beach /ID# 272922
West Palm Beach, Florida, United States, 33407
Actively Recruiting
17
Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 279438
Atlanta, Georgia, United States, 30318
Actively Recruiting
18
Pillar Clinical Research - Chicago /ID# 272823
Chicago, Illinois, United States, 60641
Actively Recruiting
19
Amr Conventions Research /ID# 272867
Warrenville, Illinois, United States, 60555
Actively Recruiting
20
St. Charles Psychiatric Associates /ID# 279239
Saint Charles, Missouri, United States, 63304
Actively Recruiting
21
Manhattan Behavioral Medicine /ID# 279769
New York, New York, United States, 10036
Actively Recruiting
22
University Of Cincinnati Medical Center /ID# 274160
Cincinnati, Ohio, United States, 45219
Actively Recruiting
23
The Ohio State University /ID# 272954
Columbus, Ohio, United States, 43210
Actively Recruiting
24
Sooner Clinical Research /ID# 272856
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
25
Community Clinical Research - Austin - Cross Park Drive /ID# 272940
Austin, Texas, United States, 78754
Actively Recruiting
26
Elixia - Houston /ID# 279200
Houston, Texas, United States, 77007
Actively Recruiting
27
Mind Matters Psychiatry /ID# 273536
Missouri City, Texas, United States, 77459-5204
Actively Recruiting
28
Pillar Clinical Research - Richardson /ID# 272821
Richardson, Texas, United States, 75080
Actively Recruiting
29
Family Psychiatry Of The Woodlands /ID# 275177
The Woodlands, Texas, United States, 77381
Actively Recruiting
30
Northwest Clinical Research Center /ID# 272847
Bellevue, Washington, United States, 98007
Actively Recruiting
31
Core Clinical Research /ID# 272955
Everett, Washington, United States, 98201
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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