A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression
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.
• Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 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 (0.4 - 1.2 mg/dL) or valproate (50 - 125 mg/dL).
• If taking lamotrigine, participant should be taking a dose within the FDA accepted range (50-400 mg/day, target dose is 200 mg/day) and investigator clinical judgment determines that the dose the participant is taking is likely to prevent onset of mood episodes.