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.

Study NCT00206102 Information provided by AstraZeneca

First Received on September 14, 2005. Last Updated on June 15, 2011 History of Changes

Results First Received: October 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Schizophrenia Schizoaffective Disorder
Interventions:	Drug: quetiapine fumarate Drug: risperidone

Participant Flow

Hide Participant Flow

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

Hide Baseline Characteristics

Reporting Groups

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

Baseline Measures

	Quetiapine Fumarate	Risperidone	Total
Number of Participants [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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca

Limitations and Caveats

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	MSD, 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:	June 15, 2011
Health Authority:	United States: Food and Drug Administration