CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 381 enrolled
Drug / intervention
quetiapine fumaratedrug
Likely dose
Quetiapine fumarate 400–800 mg daily (flexible dosing)AI-extracted
Key inclusion· 4
  • ✓Prior enrollment in double-blind Study D1441C00149 or D1441C00112
  • ✓Documented clinical diagnosis of schizophrenia or bipolar I disorder
  • ✓Able to provide written assent (child) and parent/legal guardian able to provide written informed consent
  • ✓Parent or legal guardian able to accompany patient to each scheduled study visit
Key exclusion· 3
  • ✕Pregnancy or lactation (females)
  • ✕Known intolerance or lack of response to previous quetiapine treatment
  • ✕Prior participation in this study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00227305
NCT00227305Phase 3Completed
CompareCT.gov

A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)

AstraZeneca·interventional·Posted Sep 28, 2005·Updated Jan 8, 2013

In Brief

A Phase 3 clinical trial evaluating quetiapine fumarate for Schizophrenia and Bipolar I Disorder. Completed, enrolled 381 participants across 48 sites in 9 countries.

Detailed Summary

The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Bipolar I Disorder
CountriesIndia, Malaysia, Philippines, Poland, Russia, Serbia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartAug 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

quetiapine fumaratedrug

Oral dosing, flexible dosing