A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Recruiting · NCT06696755 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
IcalcaprantPlacebo for Icalcaprant
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
33 locations listed across 13 US states.
- University of Alabama - Huntsville Regional Medical Campus /ID# 272951 - Huntsville, Alabama, United States
- Chandler Clinical Research Trials /ID# 274500 - Chandler, Arizona, United States
- Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767 - Tucson, Arizona, United States
- Sanro Clinical Research Group /ID# 279462 - Bryant, Arkansas, United States
- Advanced Research Center /ID# 272828 - Anaheim, California, United States
- Collaborative Neuroscience Research - Garden Grove /ID# 271917 - Garden Grove, California, United States
- Catalina Research Institute /ID# 272831 - Montclair, California, United States
- Excell Research /ID# 272854 - Oceanside, California, United States
- Pacific Neuropsychiatric Specialists - Orange /ID# 273118 - Orange, California, United States
- Schuster Medical Research Institute /ID# 272848 - Sherman Oaks, California, United States
- Sarkis Clinical Trials- Gainesville /ID# 272861 - Gainesville, Florida, United States
- CenExel Hollywood FL /ID# 273101 - Hollywood, Florida, United States
- Accel Research Sites Network - St. Pete /ID# 272962 - Largo, Florida, United States
- Apg Research /ID# 272925 - Orlando, Florida, United States
- Combined Research Orlando /ID# 279458 - Orlando, Florida, United States
- Clinical Research Center Of Florida /ID# 278790 - Pompano Beach, Florida, United States
- St. Johns Center for Clinical Research - Saint Augustine Location /ID# 279465 - Saint Augustine, Florida, United States
- Neuroscience Institute - West Palm Beach /ID# 272922 - West Palm Beach, Florida, United States
- Georgia Psychiatric Consultants and Advanced Discovery Research /ID# 279438 - Atlanta, Georgia, United States
- Pillar Clinical Research - Chicago /ID# 272823 - Chicago, Illinois, United States
- Amr Conventions Research /ID# 272867 - Warrenville, Illinois, United States
- Saint Charles Psychiatric Associates /ID# 279239 - Saint Charles, Missouri, United States
- Manhattan Behavioral Medicine /ID# 279769 - New York, New York, United States
- University Of Cincinnati Medical Center /ID# 274160 - Cincinnati, Ohio, United States
- The Ohio State University /ID# 272954 - Columbus, Ohio, United States
- Sooner Clinical Research /ID# 272856 - Oklahoma City, Oklahoma, United States
- Community Clinical Research - Cross Park Drive /ID# 272940 - Austin, Texas, United States
- Elixia - Houston /ID# 279200 - Houston, Texas, United States
- Mind Matters Psychiatry /ID# 273536 - Missouri City, Texas, United States
- Pillar Clinical Research - Richardson /ID# 272821 - Richardson, Texas, United States
- Family Psychiatry Of The Woodlands /ID# 275177 - The Woodlands, Texas, United States
- Northwest Clinical Research Center /ID# 272847 - Bellevue, Washington, United States
- Core Clinical Research /ID# 272955 - Everett, Washington, United States