RecruitingPhase 2NCT06696755

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

Sponsor

AbbVie

Enrollment

195 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Bipolar I Disorder Bipolar II Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral medication called icalcaprant for adults experiencing a depressive episode related to bipolar I or II disorder, to see how safe it is and whether it helps reduce depression symptoms. **You may be eligible if...** - You have been diagnosed with bipolar I or II disorder (without psychotic features) - You are currently in a major depressive episode that started at least 4 weeks ago but not more than 6 months ago - Your body mass index (BMI) is between 18 and 35 - You are in generally good health aside from your bipolar diagnosis **You may NOT be eligible if...** - You have psychotic features alongside your bipolar disorder - Your depressive episode is outside the required timeframe - You have other significant health conditions that could affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIcalcaprant

Oral Capsules

DRUGPlacebo for Icalcaprant

Oral Capsules

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

CenExel Hollywood FL /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

View Full Details on ClinicalTrials.gov

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NCT06696755

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