Pediatric Bipolar Depression
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00811473
First received: December 18, 2008
Last updated: March 21, 2012
Last verified: March 2012
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Results First Received: October 27, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Bipolar Depression |
| Interventions: |
Drug: Quetiapine XR Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| This multicenter study was conducted between 27 January 2009 and 1 November 2010, which included the recall visit. The recall visit occurred from 5 June 2010 till 1 November 2010. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| The study had an up to 35-day enrollment period, 8-week double-blind treatment period with 1 of 2 treatment regimens (quetiapine XR 150 to 300 mg/day or placebo), 1-week safety follow-up period, 2- to 4-week safety follow-up period for patients with BP >95th percentile at completion/discontinuation. |
Reporting Groups
| Description | |
|---|---|
| Quetiapine XR | Quetiapine XR 150 to 300mg once a day |
| Placebo | Matching placebo |
Participant Flow: Overall Study
| Quetiapine XR | Placebo | |
|---|---|---|
| STARTED | 93 | 100 |
| COMPLETED | 70 | 74 |
| NOT COMPLETED | 23 | 26 |
| Adverse Event | 3 | 12 |
| Lost to Follow-up | 5 | 1 |
| Withdrawal by Subject | 2 | 4 |
| Severe non-compliance to protocol | 2 | 4 |
| Lack of therapeutic response | 4 | 1 |
| Condition under investigation worsened | 1 | 3 |
| Other 2 | 4 | 1 |
| Incorrect Enrollment | 1 | 0 |
| Safety Reasons | 1 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Quetiapine XR | Quetiapine XR 150 to 300mg once a day |
| Placebo | Matching placebo |
| Total | Total of all reporting groups |
Baseline Measures
| Quetiapine XR | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
92 | 100 | 192 |
|
Age
[1] [units: years] Mean ± Standard Deviation |
13.9 ± 2.18 | 14.0 ± 2.05 | 14.0 ± 2.11 |
|
Gender
[1] [units: participants] |
|||
| Female | 47 | 48 | 95 |
| Male | 45 | 52 | 97 |
| [1] | Safety analysis set |
|---|
Outcome Measures
| 1. Primary: | 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 ] |
| 2. Secondary: | 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 ] |
| 3. Secondary: | 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 ] |
| 4. Secondary: | Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S [ Time Frame: Change from Baseline to Day 57 ] |
| 5. Secondary: | CGI-BP-C Score at Final Assessment (Day 57) [ Time Frame: Change from Baseline to day 57 ] |
| 6. Secondary: | The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness [ Time Frame: Day 57 ] |