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

Launched by ABBVIE · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Icalcaprant, aimed at helping adults with Bipolar I or II disorder, particularly during depressive episodes. The trial will involve about 237 adult participants who will be divided into three groups; some will receive the Icalcaprant capsules, while others will receive a placebo, which looks like the medication but does not contain any active ingredients. Participants will take the capsules daily for six weeks and will be monitored closely for any side effects and changes in their mood, with follow-up assessments for four weeks after treatment.

To be eligible for the trial, participants must be adults diagnosed with Bipolar I or II disorder, currently experiencing a depressive episode that started between four to six months ago. Other requirements include being in generally good health and having a specific body weight range. Throughout the study, participants will attend regular visits to a clinic or hospital, where doctors will conduct various tests and check on their well-being. It's important to note that this trial may involve more visits and assessments than typical treatments, so participants should be prepared for that commitment.

Gender

ALL

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, 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).
• 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).