Phase 4
N=1,098
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00206102 ↗Enrolled (actual)
1,098
Serious AEs
24.1%
Results posted
Jul 2011
Primary outcome: Primary: Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale — 2; 8 Participants with C type event
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- quetiapine fumarate (Drug); risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale |
2; 8 | — |
| PRIMARY Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale |
0; 2 | — |
| PRIMARY Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale |
4; 7 | — |
| SECONDARY Change in the Positive and Negative Syndrome Scale (PANSS) Total Score |
-9.1; -8.6 | — |
| SECONDARY Change in the PANSS Positive Subscale Score |
-2.7; -2.8 | — |
| SECONDARY Change in the PANSS Negative Subscale Score |
-2.2; -1.5 | — |
| SECONDARY Change in the PANSS Psychopathology Subscale Score |
-4.2; -4.4 | — |
| SECONDARY Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score |
-0.7; -0.5 | — |
| SECONDARY Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score |
2.4; 2.7 | — |
| SECONDARY Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score |
1.2; 0.9 | — |
| SECONDARY Number of Relapses of Schizophrenia or Schizoaffective Disorder |
24; 33 | — |
| SECONDARY Change in Simpson-Angus Scale (SAS) Total Score |
-0.7; -0.4 | — |
| SECONDARY Change in Barnes Akathisia Rating Scale (BARS) Global Score |
-0.1; 0.1 | — |
| SECONDARY Change in Abnormal Involuntary Movement Scale (AIMS) Total Score |
-0.2; 0.1 | — |
| SECONDARY Number of Participants With Potential Extrapyramidal Symptoms (EPS) |
73; 106 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women age 18 to 65
- Both Eyes present with lenses intact (no previous cataract extractions)
- Stable place of residency
Exclusion Criteria
- History of corneal surgery
- Legal blindness (defined as best corrected visual acuity of 20/200 or worse in one or both eyes
- Previous participation in this study
Data sourced from ClinicalTrials.gov (NCT00206102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.