At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 96 enrolled
Drug / intervention
Quetiapine Fumarate XRdrug
Likely dose
Not stated in 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.
A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients
In Brief
A Phase 4 clinical trial evaluating Quetiapine Fumarate XR for Schizophrenia. Completed, enrolled 96 participants across 7 sites.
Detailed Summary
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartNov 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedOct 24, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.7 years ago
Interventions
Quetiapine Fumarate XRdrug
oral, once daily, flexible dose