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Pediatric Bipolar Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00811473
First received: December 18, 2008
Last updated: July 2, 2014
Last verified: July 2014
  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 3

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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57) [ Time Frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57 ] [ 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:
  • Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57). [ Time Frame: Days 8 to 57 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 8 to 57 ] [ Designated as safety issue: No ]
    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 [ 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.

  • The 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. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment.


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: Quetiapine XR Drug: Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
Other Name: Seroquel XR
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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: July 2, 2014
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
Behavioral Symptoms
Mental Disorders
Mood Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014