Pediatric Bipolar Depression - Full Text View

Sponsor:	AstraZeneca
Information provided by:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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 ]

Secondary Outcome Measures:

Changes in CDRS-R scores in reduction, remission and change in total score [ Time Frame: Will be scored at all visits ] [ Designated as safety issue: No ]
Changes in CGI-BP-S and CGI-BP-C score [ Time Frame: Will be scored at all visits ] [ Designated as safety issue: No ]
Incidence of AE's, including extrapyramidal symptoms (EPS) and other specific safety areas, including somnolence, suicidality, neutropenia/agranulocytosis and thyroid function [ Time Frame: Will be measured during the whole study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	194
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
1: Experimental	Drug: quetiapine XR Oral treatment with 150 up to 300 mg/day once daily in the evening
2: Placebo Comparator	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 Pharmaceuticals ( Hans A. Eriksson, Medical Science Director, Seroquel )
Study ID Numbers:	D144AC00001
Study First Received:	December 18, 2008
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00811473 History of Changes
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:

Depression
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010