Clinical trial NCT00811473: Pediatric Bipolar Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar Depression
Depression
Children
Adolescents
Seroquel
Bipolar Depression in Children and Adolescents
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 193
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
timeFrame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Secondary outcomes:
measure: Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
timeFrame: Days 8 to 57
measure: 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
timeFrame: Days 8 to 57
measure: Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
timeFrame: Change from Baseline to Day 57
measure: CGI-BP-C Score at Final Assessment (Day 57)
timeFrame: Change from Baseline to day 57
measure: The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
timeFrame: Day 57
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Escondido
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Eagle
country: United States
facility: Research Site
state: Idaho
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Terre Haute
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Clinton Township
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Rochester
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Mason
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Wharton
country: United States
facility: Research Site
state: Texas
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Bothell
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Bogota D.c
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bello
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: Vijaywada
country: India
facility: Research Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Varanasi
country: India
facility: Research Site
state: Uttar Prad
city: Leon
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Research Site
state: W Cape
city: Changhua
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Michael Castiglione
role: STUDY_DIRECTOR
affiliation: University Hospitals Case Medical CenterCase Western Reserve University School of Medicine
name: Robert L. Findling
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.