At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,098 enrolled
Drug / intervention
quetiapine fumarate +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age 18 to 65 years
- ✓Both eyes present with intact natural lenses (no prior cataract surgery)
- ✓Stable place of residency
Key exclusion· 3
- ✕History of corneal surgery
- ✕Legal blindness (best corrected visual acuity ≤20/200 in one or both eyes)
- ✕Previous participation in this study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open Label, Flexible-dose, Parallel-group Evaluation of the Cataractogenic Potential of Quetiapine Fumarate (Seroquel) and Risperidone (Risperdal) in the Long Term Treatment of Participants With Schizophrenia or Schizoaffective Disorder
In Brief
A Phase 4 clinical trial evaluating quetiapine fumarate and risperidone for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 1,098 participants across 63 sites.
Detailed Summary
This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic potential.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
First PostedSep 2005
Primary CompletionOct 2008
TodayJul 2026
First PostedSep 21, 2005
Enrollment StartSep 1, 2003
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago
Interventions
quetiapine fumaratedrug
flexible dose oral
risperidonedrug
flexible dose oral