CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Quetiapine +1 moredrug
Likely dose
Quetiapine 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00817648
NCT00817648Phase 4Completed

A 6-Week, Multicenter, Rater-blind, Randomized, Risperidone-controlled Study to Evaluate the Efficacy and Safety of Seroquel (Quetiapine Fumarate) in the Treatment of Chinese Han Patients With Schizophrenia

Shanghai Mental Health Center·interventional·Posted Jan 6, 2009·Updated Jun 15, 2010

In Brief

A Phase 4 clinical trial evaluating Quetiapine and risperidone for Schizophrenia. Completed, enrolled 120 participants across 4 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of seroquel in the treatment of patients with acute schizophrenia compared with risperidone by evaluating the change of PANSS total score from the baseline to week 6.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2009
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.5 years ago

Interventions

Quetiapinedrug

Quetiapine fumarate, 25mg/200 mg, the dose titration is carried in week 1. flexible doses(600-750 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.

risperidonedrug

risperidone, 1mg/tablet, the dose titration is carried in week 1. flexible doses(3-6 mg/d) from week 2 to week 6. If a patient is intolerant, the doses can be adjusted as judged by investigator.