A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder
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|ClinicalTrials.gov Identifier: NCT04777357|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
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. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.
Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.
Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly 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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Bipolar I Disorder||Drug: Cariprazine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Participants (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||January 31, 2024|
Placebo Comparator: Placebo
Participants will receive Placebo over a 6 week treatment period.
Participants will receive flexible dose Cariprazine over a 6 week treatment period.
Other Name: Vraylar
- Number of Participants with Adverse Events [ Time Frame: Baseline (Week 0) to Week 10 ]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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.
- Abnormal Change from Baseline in Vital Signs [ Time Frame: Baseline (Week 0) to Week 10 ]Change in vital signs like systolic and diastolic blood pressure will be assessed.
- Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results [ Time Frame: Baseline (Week 0) to Week 6 ]Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.
- Change in Electrocardiogram (ECG) [ Time Frame: Baseline (Week 0) to Week 6 ]12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
- Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score [ Time Frame: Baseline (Week 0) to Week 10 ]The CDRS-R is a 17 item scale with items ranging from 1 to 5 or 1 to 7 used to assess depression and change in depression symptoms in children and adolescents. Scores greater than or equal to 40 are indicative of depression. Scores less than or equal to 28 are often used to define minimal or no symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777357
|Contact: Clinical Trials Registry Teamfirstname.lastname@example.org|
|Study Director:||AbbVie Inc.||AbbVie|