Pediatric Bipolar Depression

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811473
• Other study ID #: D144AC00001
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2008
• Last updated: July 2, 2014
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
• Placebo
Oral treatment once daily in the evening

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Colombia,  India,  Mexico,  Serbia,  South Africa,  Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 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	No
Secondary	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	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	No
Secondary	Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S	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	No
Secondary	CGI-BP-C Score at Final Assessment (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	No
Secondary	The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness	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	No

External Links

•   CSR-D144AC00001.pdf
•   D144AC00001_Redacted_Study_Protocol