A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m².
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Icalcaprant
DrugOral Capsules
Placebo for Icalcaprant
DrugOral Capsules
Treatment groups
195 Participants
are divided into 3 treatment groupsGroup A: Group 1: Icalcaprant Dose AExperimental treatment 1 intervention
Group B: Group 2: Icalcaprant Dose BExperimental treatment 1 intervention
Group C: Group 3: Placebo for IcalcaprantPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score
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).
Time frame
Up to approximately Week 62
Number of Participants with Adverse Events (AEs)
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
Time frame
Up to approximately 10 weeksSecondary outcomes
1
Change from Baseline to Week 6 in Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) score
Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) is a clinician-reported measure of severity of mania, depression, and overall bipolar disorder. Clinicians are asked to consider their total clinical experience with bipolar subjects and assess how severely ill has the participant been during the past 7 days. Response options range from 'Normal, not ill' to 'Very severely ill'.
Time frame
Up to approximately Week 6 Source ClinicalTrials.gov