Oral icalcaprant for adults with bipolar I or II: safety and symptom change

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized interventional trial enrolls about 195 adults with bipolar I or II disorder experiencing a major depressive episode and randomizes them into three treatment arms, with roughly one-third receiving placebo. Participants take oral icalcaprant or matching placebo once daily for six weeks and are followed for safety for an additional four weeks. Key entry criteria include absence of psychotic features, a YMRS score ≤ 12, CGI-S-BP ≥ 4 for depression, BMI between 18 and 35, and stable use of a single mood stabilizer when applicable. The study will monitor adverse events and changes in disease activity measures to determine safety and preliminary signal of benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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).

Where it's running

• University of Alabama - Huntsville Regional Medical Campus /ID# 272951
  Huntsville, Alabama, United States Recruiting
• Chandler Clinical Research Trials /ID# 274500
  Chandler, Arizona, United States Recruiting
• Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767
  Tucson, Arizona, United States Recruiting
• Sanro Clinical Research Group /ID# 279462
  Bryant, Arkansas, United States Recruiting
• Advanced Research Center /ID# 272828
  Anaheim, California, United States Recruiting
• Collaborative Neuroscience Research - Garden Grove /ID# 271917
  Garden Grove, California, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.