Pediatric Bipolar Depression - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00811473

Purpose

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).

Condition	Intervention	Phase
Bipolar Depression	Drug: quetiapine XR Drug: Placebo	Phase III

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
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in the CDRS-R Total Score From Baseline to Final Assessment (Day 57) [ Time Frame: Will be scored at all visits ] [ Designated as safety issue: No ]
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:

Proportion of Remission, Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57) [ Time Frame: Days 8 to 57 ] [ Designated as safety issue: No ]
The proportion of patients with remission from Days 8 to 57 was calculated.
Proportion of Response, Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score [ Time Frame: Days 8 to 57 ] [ Designated as safety issue: No ]
The proportion of patients with response from Days 8 to 57 was calculated.
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S [ Time Frame: Change from Baseline to Day 57 ] [ Designated as safety issue: No ]
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) [ Time Frame: Change from Baseline to day 57 ] [ Designated as safety issue: No ]
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.
Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated

Enrollment:	193
Study Start Date:	January 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: quetiapine XR Oral treatment with 150 up to 300 mg/day once daily in the evening Other Name: Seroquel XR
Placebo Comparator: 2	Drug: Placebo Oral treatment once daily in the evening

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811473

Show 48 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Michael Castiglione	AstraZeneca
Principal Investigator:	Robert L. Findling	University Hospitals Case Medical CenterCase Western Reserve University School of Medicine

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00811473 History of Changes
Other Study ID Numbers:	D144AC00001
Study First Received:	December 18, 2008
Results First Received:	October 27, 2011
Last Updated:	October 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar Depression
Depression
Children

Adolescents
Seroquel
Bipolar Depression in Children and Adolescents

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine

Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012