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Pediatric Bipolar Depression

NCT00811473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2014-07-15

Study results available
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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

Interventions

DRUG

Quetiapine XR

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

DRUG

Placebo

Oral treatment once daily in the evening

Sponsors & Collaborators

Principal Investigators

  • Michael Castiglione · AstraZeneca

  • Robert L. Findling · University Hospitals Case Medical CenterCase Western Reserve University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811473 on ClinicalTrials.gov