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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Pills, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 4-week safety follow-up period."
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of icalcaprant and whether it helps adults with bipolar I or II disorder who are having depression. Participants take daily capsules of icalcaprant or a placebo (a pill with no active drug) for 6 weeks, followed by 4 weeks of safety checks. There is a 1 in 3 chance of getting the placebo.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed bipolar I or II disorder without psychotic symptoms, such as seeing or hearing things that are not there. The current depression episode must have started at least 4 weeks before consent and no more than 12 months before screening.
  • Have a body mass index (BMI), a measure of weight compared with height, from 18 to 35.
  • Be in generally good health based on health history, an exam, blood tests, and a heart rhythm test.
  • Have scores of at least 4 for depression and overall bipolar illness on the CGI-S-BP rating scale at screening and the starting visit.
  • Have a score of 12 or less on the YMRS scale, which measures mania (an unusually high or irritable mood), at screening and the starting visit.
  • Take only one mood stabilizer: lithium, valproate, or lamotrigine. The dose must be unchanged for at least 28 days before screening and stay the same during the study.
  • If taking lithium or valproate, have a blood level within the range required by the study at screening.
  • If taking lamotrigine, take 50–400 mg daily. The study doctor must judge that the dose is likely to prevent mood episodes.

Who can't join

  • Have had an allergic reaction or strong sensitivity to the study drug's ingredients or other drugs of the same type.
  • Have an unstable or serious health condition that could make the study unsafe or affect its results. Some conditions may be allowed if stable for more than 1 year, do not need medicines banned by the study, and the study doctor approves.
  • Have a history or signs of cancer, except treated basal cell or squamous cell skin cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (33)

AL

AR

AZ

CA

FL

GA

  • Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438 · Atlanta, GA 30318More trials in Atlanta

IL

MO

NY

OH

OK

TX

WA