Pediatric Bipolar Depression

July 2, 2014 updated by: AstraZeneca

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bello, Colombia
        • Research Site
      • Bogota, Colombia
        • Research Site
      • Medellin, Colombia
        • Research Site
    • Cundinamarca
      • Bogota D.c, Cundinamarca, Colombia
        • Research Site
  • India
    • Andh Prad
      • Vijaywada, Andh Prad, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
      • Vadodara, Gujarat, India
        • Research Site
    • Uttar Prad
      • Varanasi, Uttar Prad, India
        • Research Site
  • Mexico
      • Leon, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • Research Site
    • W Cape
      • Cape Town, W Cape, South Africa
        • Research Site
  • Taiwan
      • Changhua, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • United States
    • Alabama
      • Dothan, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • Escondido, California, United States
        • Research Site
    • Florida
      • Bradenton, Florida, United States
        • Research Site
      • Gainsville, Florida, United States
        • Research Site
      • North Miami, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Smyrna, Georgia, United States
        • Research Site
    • Idaho
      • Eagle, Idaho, United States
        • Research Site
    • Illinois
      • Hoffman Estates, Illinois, United States
        • Research Site
    • Indiana
      • Terre Haute, Indiana, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Michigan
      • Clinton Township, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
    • New York
      • Rochester, New York, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Mason, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Wharton, Texas, United States
        • Research Site
    • Virginia
      • Virginia Beach, Virginia, United States
        • Research Site
    • Washington
      • Bothell, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral treatment once daily in the evening
Experimental: Quetiapine XR
Drug: Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
Other Names:
  • Seroquel XR

What is the study measuring?

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)
Time Frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at 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).
Time Frame: Days 8 to 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
Time Frame: Days 8 to 57
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
Time Frame: Change from Baseline to Day 57
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)
Time Frame: Change from Baseline to 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
Time Frame: Day 57
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D144AC00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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