Pediatric Bipolar Depression

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Quetiapine XR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine XR<br> | Drug: Quetiapine XR<br>* Oral treatment with 150 up to 300 mg/day once daily in the evening<br>* Other names: Seroquel XR;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral treatment once daily in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | Change from Baseline to Day 57 | 
| CGI-BP-C Score at Final Assessment (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. | 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. | Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Depression, Depression, Children, Adolescents, Seroquel, Bipolar Depression in Children and Adolescents