Recruiting
Phase 2

Icalcaprant

Sponsor:

AbbVie

Code:

NCT06696755

Conditions

Bipolar I Disorder

Bipolar II Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Icalcaprant

Placebo for Icalcaprant

Study Details

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.

Conditions

Bipolar I Disorder

Bipolar II Disorder

Study ID

NCT06696755

Start date

Feb 3, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 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 (0.4 - 1.2 mg/dL) or valproate (50 - 125 mg/dL).
  • If taking lamotrigine, participant should be taking a dose within the FDA accepted range (50-400 mg/day, target dose is 200 mg/day) and investigator clinical judgment determines that the dose the participant is taking is likely to prevent onset of mood episodes.

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).

Study Design

Enrollment

195 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Icalcaprant Dose A

Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.

experimental: Group 2: Icalcaprant Dose B

Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.

placebo comparator: Group 3: Placebo for Icalcaprant

Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.

Interventions

Icalcaprant

Oral Capsules

Placebo for Icalcaprant

Oral Capsules

Primary outcome measure

  • Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score [ Time Frame: Up to approximately Week 6 ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 10 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Huntsville, Alabama, United States, 35801

Chandler Clinical Research Trials /ID# 274500

Recruiting

Chandler, Arizona, United States, 85224

Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767

Recruiting

Tucson, Arizona, United States, 85715

Sanro Clinical Research Group /ID# 279462

Recruiting

Bryant, Arkansas, United States, 72022

Advanced Research Center /ID# 272828

Recruiting

Anaheim, California, United States, 92805

Collaborative Neuroscience Research - Garden Grove /ID# 271917

Recruiting

Garden Grove, California, United States, 92845

Catalina Research Institute /ID# 272831

Recruiting

Montclair, California, United States, 91763

Excell Research /ID# 272854

Recruiting

Oceanside, California, United States, 92056

Pacific Neuropsychiatric Specialists - Orange /ID# 273118

Recruiting

Orange, California, United States, 92868

Schuster Medical Research Institute /ID# 272848

Recruiting

Sherman Oaks, California, United States, 91403

Sarkis Clinical Trials- Gainesville /ID# 272861

Recruiting

Gainesville, Florida, United States, 32607

CenExel Hollywood FL /ID# 273101

Recruiting

Hollywood, Florida, United States, 33024

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

Recruiting

Largo, Florida, United States, 33777

Apg Research /ID# 272925

Recruiting

Orlando, Florida, United States, 32803

Combined Research Orlando /ID# 279458

Recruiting

Orlando, Florida, United States, 32814

Clinical Research Center Of Florida /ID# 278790

Recruiting

Pompano Beach, Florida, United States, 33060

St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465

Recruiting

Saint Augustine, Florida, United States, 32086

Neuroscience Institute - West Palm Beach /ID# 272922

Recruiting

West Palm Beach, Florida, United States, 33407

Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438

Recruiting

Atlanta, Georgia, United States, 30318

Pillar Clinical Research - Chicago /ID# 272823

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Site Coordinator

2245347332

Amr Conventions Research /ID# 272867

Recruiting

Warrenville, Illinois, United States, 60555

Saint Charles Psychiatric Associates /ID# 279239

Recruiting

Saint Charles, Missouri, United States, 63304

Manhattan Behavioral Medicine /ID# 279769

Recruiting

New York, New York, United States, 10036

University Of Cincinnati Medical Center /ID# 274160

Recruiting

Cincinnati, Ohio, United States, 45219

The Ohio State University /ID# 272954

Recruiting

Columbus, Ohio, United States, 43210

Sooner Clinical Research /ID# 272856

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Community Clinical Research - Cross Park Drive /ID# 272940

Recruiting

Austin, Texas, United States, 78754

Elixia - Houston /ID# 279200

Recruiting

Houston, Texas, United States, 77007

Mind Matters Psychiatry /ID# 273536

Recruiting

Missouri City, Texas, United States, 77459-5204

Pillar Clinical Research - Richardson /ID# 272821

Recruiting

Richardson, Texas, United States, 75080

Family Psychiatry Of The Woodlands /ID# 275177

Recruiting

The Woodlands, Texas, United States, 77381

Northwest Clinical Research Center /ID# 272847

Recruiting

Bellevue, Washington, United States, 98007

Core Clinical Research /ID# 272955

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

AbbVie

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Bipolar I Disorder
  • Bipolar II Disorder
  • Bipolar Disorder
  • lcalcaprant
  • ABBV-1354
  • CVL-354

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-14.