The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
193
Oral treatment with 150 up to 300 mg/day once daily in the evening
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)
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).
Time frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 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).
Time frame: Days 8 to 57
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
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).
Time frame: Days 8 to 57
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
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.
Time frame: Change from Baseline to Day 57
CGI-BP-C Score at Final Assessment (Day 57)
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Research Site
Dothan, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Escondido, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
...and 38 more locations
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.
Time frame: Change from Baseline to day 57
The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
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.
Time frame: Day 57