Pediatric Bipolar Depression

NCT00811473 | Completed Phase 3 Results

• 1 other identifier: D144AC00001
• Study Type: interventional
• Target: 193
• Locations: 7 countries
• Sites: 48

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).

Conditions

Bipolar Depression

Keywords

Bipolar Depression; Depression; Children; Adolescents; Seroquel; Bipolar Depression in Children and Adolescents

Outcome Measures

Primary Outcomes (1)

• 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).

  Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57

Secondary Outcomes (5)

• Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).

  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

  Days 8 to 57

• Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S

  Change from Baseline to Day 57

• CGI-BP-C Score at Final Assessment (Day 57)

  Change from Baseline to day 57

• The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness

  Day 57

Study Arms (2)

Quetiapine XR

EXPERIMENTAL

Drug: Quetiapine XR

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quetiapine XR DRUG

Oral treatment with 150 up to 300 mg/day once daily in the evening

Also known as: Seroquel XR

Quetiapine XR

Placebo DRUG

Oral treatment once daily in the evening

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (48)

Research Site

Dothan, Alabama, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Escondido, California, United States

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Bradenton, Florida, United States

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Gainsville, Florida, United States

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North Miami, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Eagle, Idaho, United States

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Hoffman Estates, Illinois, United States

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Terre Haute, Indiana, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Clinton Township, Michigan, United States

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Minneapolis, Minnesota, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Mason, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Wharton, Texas, United States

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Virginia Beach, Virginia, United States

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Bothell, Washington, United States

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Milwaukee, Wisconsin, United States

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Bogota D.c, Cundinamarca, Colombia

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Bello, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Vijaywada, Andh Prad, India

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Ahmedabad, Gujarat, India

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Vadodara, Gujarat, India

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Varanasi, Uttar Prad, India

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León, Mexico

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Monterrey, Mexico

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Belgrade, Serbia

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Novi Sad, Serbia

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Pretoria, Gauteng, South Africa

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Cape Town, W Cape, South Africa

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Taoyuan District, Taiwan, Taiwan

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Changhua, Taiwan

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Taipei, Taiwan

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Related Publications (1)

• 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.

  PMID: 24956042 BACKGROUND

Related Links

• CSR-D144AC00001.pdf
• D144AC00001\_Redacted\_Study\_Protocol

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrail_results_posting@astrazeneca.com

Study Officials

• Michael Castiglione

  AstraZeneca

  STUDY DIRECTOR

• Robert L. Findling

  University Hospitals Case Medical CenterCase Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 15, 2014
• Results First Posted: December 1, 2011

Record last verified: 2014-07

Locations

SE (2); TW (3); US (31); IN (4); ME (2); ZA (2); CO (4)