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

NCT ID: NCT06696755

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-05
• Study Completion Date: 2027-11-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Icalcaprant Dose A

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

Group Type: EXPERIMENTAL

Icalcaprant

Intervention Type: DRUG

Oral Capsules

Group 2: Icalcaprant Dose B

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

Group Type: EXPERIMENTAL

Icalcaprant

Intervention Type: DRUG

Oral Capsules

Group 3: Placebo for Icalcaprant

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

Group Type: PLACEBO_COMPARATOR

Placebo for Icalcaprant

Intervention Type: DRUG

Oral Capsules

Interventions

Icalcaprant

Oral Capsules

Intervention Type: DRUG

Placebo for Icalcaprant

Oral Capsules

Intervention Type: DRUG

Other Intervention Names

ABBV-1354; CVL-354

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Central Contacts

ABBVIE CALL CENTER

Role: CONTACT

abbvieclinicaltrials@abbvie.com

844-663-3742

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M25-526

Related Info

Other Identifiers

M25-526

Identifier Type: -

Identifier Source: org_study_id