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

Conditions

• Bipolar I Disorder
• Bipolar II Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Icalcaprant — DRUG
  Oral Capsules
• Placebo for Icalcaprant — DRUG
  Oral Capsules

Study Details

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.

Key Dates

Start date

Feb 3, 2026

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

195 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (31)

Find similar trials in Huntsville, AL

Related Studies

• A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
  PHASE3 · Recruiting · AbbVie · Bentonville, Arkansas
• Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
  PHASE3 · Enrolling By Invitation · Alkermes, Inc. · Dothan, Alabama
• Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
  PHASE3 · Recruiting · Alkermes, Inc. · Dothan, Alabama
• Children's Bipolar Network Treatment Trial I
  Recruiting · University of California, Los Angeles · Los Angeles, California