Phase 3
N=193
Pediatric Bipolar Depression
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00811473 ↗Enrolled (actual)
193
Serious AEs
—
Results posted
Dec 2011
Primary outcome: Primary: Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) — -29.6; -27.3 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quetiapine XR (Drug); Placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) |
-29.6; -27.3 | — |
| SECONDARY Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57). |
42; 34 | — |
| 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 |
58; 55 | — |
| SECONDARY Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S |
-17.2; -1.35 | — |
| SECONDARY CGI-BP-C Score at Final Assessment (Day 57) |
2.4; 2.6 | — |
| SECONDARY The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness |
0.522; 0.40 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
- The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
- Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
- Patients must be able to swallow the study medication tablets.
Exclusion Criteria
- The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
- Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
- The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
- Patients who in your doctors judgement pose a current suicidal or homicidal risk.
Data sourced from ClinicalTrials.gov (NCT00811473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.