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

Phase 2

Not yet recruiting

• Conditions: Bipolar I Disorder; Bipolar II Disorder
• Interventions: Drug: Icalcaprant; Drug: Placebo for Icalcaprant

• Registration Number: NCT06696755
• Lead Sponsor: AbbVie

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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Study Start: 2025-05-15
• Primary Completion: 2026-10-29
• Study Completion: 2026-10-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 237

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, 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.
• CGIS-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 must have had ≥ 28 days of treatment prior to screening with valproate or lithium at therapeutic blood levels (0.4-1.5 mEq/L, 50-125 μg/mL).

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Exclusion Criteria

• History of any treatment with antidepressants for any reason within 7 days, fluoxetine within 28 days, a monoamine oxidase inhibitor within 21 days of randomization, clozapine within 120 days of randomization, or benzodiazepines or sedative hypnotics within 7 days of randomization.
• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Icalcaprant Dose A	Icalcaprant	Participants will receive oral Icalcaprant dose A once daily for 6 weeks and followed for 4 weeks.
Group 2: Icalcaprant Dose B	Icalcaprant	Participants will receive oral Icalcaprant dose B once daily for 6 weeks and followed for 4 weeks.
Group 3: Placebo for Icalcaprant	Placebo for Icalcaprant	Participants will receive oral placebo for Icalcaprant daily for 6 weeks and followed for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score	Up to approximately Week 6	MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
Number of Participants with Adverse Events (AEs)	Up to approximately 10 weeks	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 6 in the Dimensional Anhedonia Rating Scale (DARS) total score	Up to approximately Week 6	The Dimensional Anhedonia Rating Scale (DARS) is a self-report tool that measures anhedonia, or a lack of interest or pleasure in activities, across four domains: Hobbies and past-times, Food and drinks, Social activities, and Sensory experiences.; The maximum score of DARS total score is 68 and the minimum is 0. Higher scores mean a better outcome.
Change from Baseline to Week 6 in the Generalized Anxiety Disorder 7 (GAD-7) total score	Up to approximately Week 6	Generalized Anxiety Disorder-7 is a widely used questionnaire to assess the severity of symptoms related to generalized anxiety disorder. The questionnaire consists of 7 questions, each with different answer options. The respondent needs to select the appropriate answer based on their actual condition and assign a corresponding score. The total score ranges ...