Actively Recruiting
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Led by AbbVie · Updated on 2026-05-13
195
Participants Needed
31
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Diagnosed with bipolar I or II disorder without psychotic features, confirmed by MINI 7.0.2
- Currently experiencing a major depressive episode starting at least 4 weeks and no more than 6 months before screening
- Body Mass Index (BMI) between 18.0 and 35.0 kg/m²
- General good health based on medical history, physical exam, vital signs, lab tests, and ECG
- CGI-S-BP score of 4 or higher for depression and overall bipolar illness at screening and baseline
- YMRS 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 before screening
- Therapeutic blood levels for lithium (0.8 - 1.2 mg/dL) or valproate (50 - 125 mg/dL) if applicable
- Using a locally approved maintenance dose of lamotrigine if applicable
You will not qualify if you...
- History of allergic reaction or significant sensitivity to the study drug or similar products
- History or presence of medical conditions that could interfere with the study, affect results, or risk participant safety
- Unstable medical conditions or history 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, not requiring prohibited medications, and judged safe by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here