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A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206102
First received: September 14, 2005
Last updated: January 8, 2013
Last verified: January 2013
Results First Received: October 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: quetiapine fumarate
Drug: risperidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A 24-month, multi-center, evaluator masked (ophthalmologist), open-label, flexible-dose, parallel-group study, 82 sites recruited Sept 2003 through Oct 2008. In total 1099 participants were randomized by Interactive Voice Response System (IVRS). One excluded participant was randomized before the rand visit, and never returned to any study visits.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and must be cross-tapered off of all previous antipsychotic medications

Reporting Groups
  Description
Quetiapine Fumarate Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
Risperidone Risperidone - flexibly dosed (2 - 8 mg/day)

Participant Flow:   Overall Study
    Quetiapine Fumarate   Risperidone
STARTED   596   502 
COMPLETED   188   187 
NOT COMPLETED   408   315 
Adverse Event                119                82 
Protocol Violation                0                2 
Lack of therapeutic response                16                11 
Lost to Follow-up                95                66 
Withdrawal by Subject                118                101 
Study-specific discontinuation criteria                18                17 
None of those categories                42                36 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Quetiapine Fumarate Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
Risperidone Risperidone - flexibly dosed (2 - 8 mg/day)
Total Total of all reporting groups

Baseline Measures
   Quetiapine Fumarate   Risperidone   Total 
Overall Participants Analyzed 
[Units: Participants]
 596   502   1098 
Age, Customized 
[Units: Participants]
     
< 40 years   265   223   488 
40 to 65 years   331   279   610 
Gender [1] 
[Units: Participants]
     
Female   253   199   452 
Male   343   303   646 
[1] Participants in the United States (USA) randomized by the study's Interactive Voice Response System (IVRS).


  Outcome Measures
  Show All Outcome Measures

1.  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   [ Time Frame: Randomization to Month 24 ]

2.  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   [ Time Frame: Randomization to Month 24 ]

3.  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   [ Time Frame: Randomization to Month 24 ]

4.  Secondary:   Change in the Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Randomization to Month 24 ]

5.  Secondary:   Change in the PANSS Positive Subscale Score   [ Time Frame: Randomization to Month 24 ]

6.  Secondary:   Change in the PANSS Negative Subscale Score   [ Time Frame: Randomization to Month 24 ]

7.  Secondary:   Change in the PANSS Psychopathology Subscale Score   [ Time Frame: Randomization to Month 24 ]

8.  Secondary:   Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score   [ Time Frame: Randomization to Month 24 ]

9.  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   [ Time Frame: Randomization to Month 24 ]

10.  Secondary:   Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score   [ Time Frame: Randomization to Month 24 ]

11.  Secondary:   Number of Relapses of Schizophrenia or Schizoaffective Disorder   [ Time Frame: At Month 24 ]

12.  Secondary:   Change in Simpson-Angus Scale (SAS) Total Score   [ Time Frame: Randomization to Month 24 ]

13.  Secondary:   Change in Barnes Akathisia Rating Scale (BARS) Global Score   [ Time Frame: Randomization to Month 24 ]

14.  Secondary:   Change in Abnormal Involuntary Movement Scale (AIMS) Total Score   [ Time Frame: Randomization to Month 24 ]

15.  Secondary:   Number of Participants With Potential Extrapyramidal Symptoms (EPS)   [ Time Frame: From start of the study treatment to last dose plus 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00206102     History of Changes
Other Study ID Numbers: 5077IL/0089
D1441C00089
Study First Received: September 14, 2005
Results First Received: October 22, 2009
Last Updated: January 8, 2013