Pediatric Bipolar Depression
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|ClinicalTrials.gov Identifier: NCT00811473|
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : December 1, 2011
Last Update Posted : July 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: Quetiapine XR Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Experimental: Quetiapine XR||
Drug: Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
Other Name: Seroquel XR
|Placebo Comparator: Placebo||
Oral treatment once daily in the evening
- Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) [ Time Frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57 ]Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
- Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57). [ Time Frame: Days 8 to 57 ]The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
- The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score [ Time Frame: Days 8 to 57 ]The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
- Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S [ Time Frame: Change from Baseline to Day 57 ]The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.
- CGI-BP-C Score at Final Assessment (Day 57) [ Time Frame: Change from Baseline to day 57 ]The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.
- The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness [ Time Frame: Day 57 ]The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment.
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): NCT00811473
Show 48 Study Locations
|Study Director:||Michael Castiglione||AstraZeneca|
|Principal Investigator:||Robert L. Findling||University Hospitals Case Medical CenterCase Western Reserve University School of Medicine|