Back to resultsA Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
quetiapine fumarate
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Quetiapine fumarate
Risperidone
Outcomes
Primary Outcome Measures
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
Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.
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
Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
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
Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
Secondary Outcome Measures
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score.
Change in the PANSS Positive Subscale Score
PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree.
Change in the PANSS Negative Subscale Score
PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score.
Change in the PANSS Psychopathology Subscale Score
PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= "absent" psychosis symptom, 7= "extreme" symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score.
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.
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
Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization
Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization
Number of Relapses of Schizophrenia or Schizoaffective Disorder
Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.
Change in Simpson-Angus Scale (SAS) Total Score
SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.
Change in Barnes Akathisia Rating Scale (BARS) Global Score
BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.
Number of Participants With Potential Extrapyramidal Symptoms (EPS)
Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00206102
Brief Title
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1098 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Quetiapine fumarate
Arm Title
2
Arm Type
Active Comparator
Arm Description
Risperidone
Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate
Other Intervention Name(s)
Seroquel, ICI 204,636
Intervention Description
flexible dose oral
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
flexible dose oral
Primary Outcome Measure Information:
Title
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
Description
Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.
Time Frame
Randomization to Month 24
Title
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
Description
Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
Time Frame
Randomization to Month 24
Title
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
Description
Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.
Time Frame
Randomization to Month 24
Secondary Outcome Measure Information:
Title
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
Description
PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score.
Time Frame
Randomization to Month 24
Title
Change in the PANSS Positive Subscale Score
Description
PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree.
Time Frame
Randomization to Month 24
Title
Change in the PANSS Negative Subscale Score
Description
PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score.
Time Frame
Randomization to Month 24
Title
Change in the PANSS Psychopathology Subscale Score
Description
PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= "absent" psychosis symptom, 7= "extreme" symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score.
Time Frame
Randomization to Month 24
Title
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Description
CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.
Time Frame
Randomization to Month 24
Title
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
Description
Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization
Time Frame
Randomization to Month 24
Title
Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
Description
PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization
Time Frame
Randomization to Month 24
Title
Number of Relapses of Schizophrenia or Schizoaffective Disorder
Description
Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.
Time Frame
At Month 24
Title
Change in Simpson-Angus Scale (SAS) Total Score
Description
SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.
Time Frame
Randomization to Month 24
Title
Change in Barnes Akathisia Rating Scale (BARS) Global Score
Description
BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.
Time Frame
Randomization to Month 24
Title
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
Description
AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.
Time Frame
Randomization to Month 24
Title
Number of Participants With Potential Extrapyramidal Symptoms (EPS)
Description
Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor
Time Frame
From start of the study treatment to last dose plus 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Mabelvale
State/Province
Arkansas
Country
United States
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City
Morrilton
State/Province
Arkansas
Country
United States
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City
Anaheim
State/Province
California
Country
United States
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City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
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City
Garden Grove
State/Province
California
Country
United States
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Long Beach
State/Province
California
Country
United States
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City
Los Angeles
State/Province
California
Country
United States
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City
Orange
State/Province
California
Country
United States
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San Diego
State/Province
California
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United States
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San Marcos
State/Province
California
Country
United States
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Denver
State/Province
Colorado
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United States
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New Britian
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Connecticut
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United States
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Boca Raton
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Florida
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United States
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Boynton Beach
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Florida
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United States
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Deerfield Beach
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Florida
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United States
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Ft Lauderdale
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Florida
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United States
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Orlando
State/Province
Florida
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United States
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Pompano Beach
State/Province
Florida
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United States
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City
Tampa
State/Province
Florida
Country
United States
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W. Palm Beach
State/Province
Florida
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United States
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West Palm Beach
State/Province
Florida
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United States
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Atlanta
State/Province
Georgia
Country
United States
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Augusta
State/Province
Georgia
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United States
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Chicago
State/Province
Illinois
Country
United States
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City
Joliet
State/Province
Illinois
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United States
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City
Oak Brook Terrace
State/Province
Illinois
Country
United States
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City
Schaumburg
State/Province
Illinois
Country
United States
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City
Newton
State/Province
Kansas
Country
United States
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City
Wichita
State/Province
Kansas
Country
United States
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City
Metairie
State/Province
Louisiana
Country
United States
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New Orleans
State/Province
Louisiana
Country
United States
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City
Glen Burnie
State/Province
Maryland
Country
United States
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City
Minneapolis
State/Province
Minnesota
Country
United States
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St. Louis
State/Province
Missouri
Country
United States
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Las Vegas
State/Province
Nevada
Country
United States
Facility Name
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City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Paramus
State/Province
New Jersey
Country
United States
Facility Name
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City
Stratford
State/Province
New Jersey
Country
United States
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City
Brooklyn
State/Province
New York
Country
United States
Facility Name
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City
New York
State/Province
New York
Country
United States
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City
Staten Island
State/Province
New York
Country
United States
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Beechwood
State/Province
Ohio
Country
United States
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City
Cincinnati
State/Province
Ohio
Country
United States
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Dayton
State/Province
Ohio
Country
United States
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City
Lyndhurst
State/Province
Ohio
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United States
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Medina
State/Province
Ohio
Country
United States
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City
Oklahoma City
State/Province
Oklahoma
Country
United States
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City
Portland
State/Province
Oregon
Country
United States
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City
Media
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
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City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
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Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
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City
Houston
State/Province
Texas
Country
United States
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City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Midvale
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Falls Church
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
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