Back to resultsPediatric Bipolar Depression
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine XR
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar Depression, Depression, Children, Adolescents, Seroquel, Bipolar Depression in Children and Adolescents
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Quetiapine XR
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811473
Brief Title
Pediatric Bipolar Depression
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar Depression, Depression, Children, Adolescents, Seroquel, Bipolar Depression in Children and Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine XR
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
Oral treatment with 150 up to 300 mg/day once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral treatment once daily in the evening
Primary Outcome Measure Information:
Title
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
Description
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
Secondary Outcome Measure Information:
Title
Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
Description
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
Title
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
Description
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
Title
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
Description
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
Title
CGI-BP-C Score at Final Assessment (Day 57)
Description
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
Title
The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Castiglione
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert L. Findling
Organizational Affiliation
University Hospitals Case Medical CenterCase Western Reserve University School of Medicine
Official's Role
Principal Investigator
Facility Information:
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Dothan
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Alabama
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United States
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Scottsdale
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United States
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Little Rock
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Escondido
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Bradenton
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Atlanta
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Smyrna
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Eagle
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Hoffman Estates
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Clinton Township
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Rochester
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Cincinnati
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Cleveland
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Mason
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Oklahoma City
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Charleston
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Memphis
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Wharton
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Virginia Beach
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Milwaukee
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Bogota D.c
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Cundinamarca
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Colombia
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Bello
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Colombia
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Bogota
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Colombia
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Medellin
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Colombia
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Vijaywada
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Andh Prad
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India
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Ahmedabad
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Gujarat
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India
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Vadodara
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Gujarat
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India
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Varanasi
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Uttar Prad
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India
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Leon
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Mexico
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Monterrey
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Mexico
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Belgrade
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Serbia
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Novi Sad
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Serbia
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Pretoria
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Gauteng
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South Africa
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Cape Town
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W Cape
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South Africa
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Changhua
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24956042
Citation
Findling RL, Pathak S, Earley WR, Liu S, DelBello MP. Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2014 Aug;24(6):325-35. doi: 10.1089/cap.2013.0105. Epub 2014 Jun 23.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=276&filename=CSR-D144AC00001.pdf
Description
CSR-D144AC00001.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=276&filename=D144AC00001_Redacted_RRB_1516423827582625983.pdf
Description
D144AC00001_Redacted_Study_Protocol
Learn more about this trial
Pediatric Bipolar Depression
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