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

Study Identifier
M25-526
CT.gov Identifier
NCT06696755
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Bipolar Disorder
    • Study Drug
  • Icalcaprant
  • Placebo for Icalcaprant
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion 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).

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    University of Alabama - Huntsville Regional Medical Campus /ID# 272951
    Huntsville, Alabama, United States, 35801
    Status
    Recruiting
    Location
    Chandler Clinical Research Trials /ID# 274500
    Chandler, Arizona, United States, 85224
    Status
    Recruiting
    Location
    Sanro Clinical Research Group /ID# 279462
    Bryant, Arkansas, United States, 72022
    Status
    Recruiting
    Location
    Advanced Research Center /ID# 272828
    Anaheim, California, United States, 92805
    Status
    Recruiting
    Location
    Collaborative Neuroscience Research - Garden Grove /ID# 271917
    Garden Grove, California, United States, 92845
    Status
    Recruiting
    Location
    Catalina Research Institute, LLC /ID# 272831
    Montclair, California, United States, 91763
    Status
    Recruiting
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