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RECRUITING

NCT06696755

PHASE2

A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2026-02-03

Completion Date

2027-11

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Bipolar I Disorder Bipolar II Disorder

Interventions

DRUG

Icalcaprant

Oral Capsules

DRUG

Placebo for Icalcaprant

Oral Capsules

Inclusion Criteria: * 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. 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. * 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).

Locations (29)

University of Alabama - Huntsville Regional Medical Campus /ID# 272951

Huntsville, Alabama, United States

Chandler Clinical Research Trials /ID# 274500

Chandler, Arizona, United States

Sanro Clinical Research Group /ID# 279462

Bryant, Arkansas, United States

Advanced Research Center /ID# 272828

Anaheim, California, United States

Collaborative Neuroscience Research - Garden Grove /ID# 271917

Garden Grove, California, United States

Catalina Research Institute, LLC /ID# 272831

Montclair, California, United States

Excell Research /ID# 272854

Oceanside, California, United States

Pacific Neuropsychiatric Specialists - Orange /ID# 273118

Orange, California, United States

Schuster Medical Research Institute /ID# 272848

Sherman Oaks, California, United States

CenExcel Clinical Research - Main Facility /ID# 273101

Hollywood, Florida, United States

Accel Research Sites Network - St. Pete /ID# 272962

Largo, Florida, United States

Apg Research /ID# 272925

Orlando, Florida, United States

Combined Research Orlando Phase I-IV /ID# 279458

Orlando, Florida, United States

Clinical Research Center Of Florida /ID# 278790

Pompano Beach, Florida, United States

Neuroscience Institute - West Palm Beach /ID# 272922

West Palm Beach, Florida, United States

Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 279438

Atlanta, Georgia, United States

Pillar Clinical Research - Chicago /ID# 272823

Chicago, Illinois, United States

Amr Conventions Research /ID# 272867

Warrenville, Illinois, United States

St. Charles Psychiatric Associates /ID# 279239

Saint Charles, Missouri, United States

Manhattan Behavioral Medicine /ID# 279769

New York, New York, United States

University Of Cincinnati Medical Center /ID# 274160

Cincinnati, Ohio, United States

The Ohio State University /ID# 272954

Columbus, Ohio, United States

Sooner Clinical Research /ID# 272856

Oklahoma City, Oklahoma, United States

Community Clinical Research - Austin - Cross Park Drive /ID# 272940

Austin, Texas, United States

Elixia - Houston /ID# 279200

Houston, Texas, United States

Pillar Clinical Research - Richardson /ID# 272821

Richardson, Texas, United States

Family Psychiatry Of The Woodlands /ID# 275177

The Woodlands, Texas, United States

Northwest Clinical Research Center /ID# 272847

Bellevue, Washington, United States

Core Clinical Research /ID# 272955

Everett, Washington, United States