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

AbbVie · NCT06696755

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
195
US sites recruiting
33
Study start
February 3, 2026
Record last updated
August 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Icalcaprant; Placebo for Icalcaprant

Conditions: Bipolar I Disorder; Bipolar II Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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).

Recruiting US locations

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

    Huntsville, AL 35801

  • Chandler Clinical Research Trials /ID# 274500

    Chandler, AZ 85224

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

    Tucson, AZ 85715

  • Sanro Clinical Research Group /ID# 279462

    Bryant, AR 72022

  • Advanced Research Center /ID# 272828

    Anaheim, CA 92805

  • Collaborative Neuroscience Research - Garden Grove /ID# 271917

    Garden Grove, CA 92845

  • Catalina Research Institute /ID# 272831

    Montclair, CA 91763

  • Excell Research /ID# 272854

    Oceanside, CA 92056

  • Pacific Neuropsychiatric Specialists - Orange /ID# 273118

    Orange, CA 92868

  • Schuster Medical Research Institute /ID# 272848

    Sherman Oaks, CA 91403

  • Sarkis Clinical Trials- Gainesville /ID# 272861

    Gainesville, FL 32607

  • CenExel Hollywood FL /ID# 273101

    Hollywood, FL 33024

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

    Largo, FL 33777

  • Apg Research /ID# 272925

    Orlando, FL 32803

  • Combined Research Orlando /ID# 279458

    Orlando, FL 32814

  • Clinical Research Center Of Florida /ID# 278790

    Pompano Beach, FL 33060

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

    Saint Augustine, FL 32086

  • Neuroscience Institute - West Palm Beach /ID# 272922

    West Palm Beach, FL 33407

  • Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438

    Atlanta, GA 30318

  • Pillar Clinical Research - Chicago /ID# 272823

    Chicago, IL 60641

    Site contact: Site Coordinator · 2245347332

  • Amr Conventions Research /ID# 272867

    Warrenville, IL 60555

  • Saint Charles Psychiatric Associates /ID# 279239

    Saint Charles, MO 63304

  • Manhattan Behavioral Medicine /ID# 279769

    New York, NY 10036

  • University Of Cincinnati Medical Center /ID# 274160

    Cincinnati, OH 45219

  • The Ohio State University /ID# 272954

    Columbus, OH 43210

  • Sooner Clinical Research /ID# 272856

    Oklahoma City, OK 73116

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

    Austin, TX 78754

  • Elixia - Houston /ID# 279200

    Houston, TX 77007

  • Mind Matters Psychiatry /ID# 273536

    Missouri City, TX 77459-5204

  • Pillar Clinical Research - Richardson /ID# 272821

    Richardson, TX 75080

  • Family Psychiatry Of The Woodlands /ID# 275177

    The Woodlands, TX 77381

  • Northwest Clinical Research Center /ID# 272847

    Bellevue, WA 98007

  • Core Clinical Research /ID# 272955

    Everett, WA 98201

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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