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

Official title

A Phase 2, Multicenter, 6-Week, Double Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Bipolar Depression

Overview

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.

Interventions

• Drug Icalcaprant
  Oral Capsules
• Drug Placebo for Icalcaprant
  Oral Capsules

Primary outcome measures

• Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score [Time frame: Up to approximately Week 6]
• Number of Participants with Adverse Events (AEs) [Time frame: Up to approximately 10 weeks]

Secondary outcome measures (1)

• Change from Baseline to Week 6 in Clinician Global Impression of Severity - Bipolar Disorder (CGI-S-BP) score [Time frame: Up to approximately Week 6]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 33 centers

• University of Alabama - Huntsville Regional Medical Campus /ID# 272951 — Huntsville
• Chandler Clinical Research Trials /ID# 274500 — Chandler
• Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767 — Tucson
• Sanro Clinical Research Group /ID# 279462 — Bryant
• Advanced Research Center /ID# 272828 — Anaheim
• Collaborative Neuroscience Research - Garden Grove /ID# 271917 — Garden Grove
• Catalina Research Institute /ID# 272831 — Montclair
• Excell Research /ID# 272854 — Oceanside
• … and 25 more centers

Identifiers

NCT: NCT06696755 · M25-526

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗