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Pediatric Bipolar Depression

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Depression

Intervention: Quetiapine XR (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Castiglione, Study Director, Affiliation: AstraZeneca
Robert L. Findling, Principal Investigator, Affiliation: University Hospitals Case Medical CenterCase Western Reserve University School of Medicine

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)

Secondary outcome:

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

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

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

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

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Bello, Colombia

Research Site, Bogota, Colombia

Research Site, Medellin, Colombia

Research Site, Leon, Mexico

Research Site, Monterrey, Mexico

Research Site, Belgrade, Serbia

Research Site, Novi Sad, Serbia

Research Site, Changhua, Taiwan

Research Site, Taipei, Taiwan

Research Site, Taoyuan, Taiwan

Research Site, Dothan, Alabama, United States

Research Site, Vijaywada, Andh Prad, India

Research Site, Scottsdale, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Escondido, California, United States

Research Site, Bogota D.c, Cundinamarca, Colombia

Research Site, 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, Pretoria, Gauteng, South Africa

Research Site, Atlanta, Georgia, United States

Research Site, Smyrna, Georgia, United States

Research Site, Ahmedabad, Gujarat, India

Research Site, Vadodara, Gujarat, India

Research Site, Eagle, Idaho, United States

Research Site, Hoffman Estates, Illinois, United States

Research Site, Terre Haute, Indiana, United States

Research Site, Overland Park, Kansas, United States

Research Site, Wichita, Kansas, United States

Research Site, Clinton Township, Michigan, United States

Research Site, Minneapolis, Minnesota, United States

Research Site, Flowood, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Lincoln, Nebraska, United States

Research Site, Rochester, New York, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Cleveland, Ohio, United States

Research Site, Mason, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Charleston, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Wharton, Texas, United States

Research Site, Varanasi, Uttar Prad, India

Research Site, Virginia Beach, Virginia, United States

Research Site, Cape Town, W Cape, South Africa

Research Site, Bothell, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Additional Information

CSR-D144AC00001.pdf

D144AC00001_Redacted_Study_Protocol

Related publications:

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.

Starting date: January 2009
Last updated: July 2, 2014

Page last updated: August 23, 2015

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