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

January 8, 2013 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1098

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
      • Mabelvale, Arkansas, United States
        • Research Site
      • Morrilton, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Cerritos, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Marcos, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Connecticut
      • New Britian, Connecticut, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Boynton Beach, Florida, United States
        • Research Site
      • Deerfield Beach, Florida, United States
        • Research Site
      • Ft Lauderdale, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Pompano Beach, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • W. Palm Beach, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Augusta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Joliet, Illinois, United States
        • Research Site
      • Oak Brook Terrace, Illinois, United States
        • Research Site
      • Schaumburg, Illinois, United States
        • Research Site
    • Kansas
      • Newton, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Research Site
      • New Orleans, Louisiana, United States
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Cherry Hill, New Jersey, United States
        • Research Site
      • Moorestown, New Jersey, United States
        • Research Site
      • Paramus, New Jersey, United States
        • Research Site
      • Stratford, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Staten Island, New York, United States
        • Research Site
    • Ohio
      • Beechwood, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Lyndhurst, Ohio, United States
        • Research Site
      • Medina, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Media, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Irving, Texas, United States
        • Research Site
      • McKinney, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Midvale, Utah, United States
        • Research Site
    • Virginia
      • Arlington, Virginia, United States
        • Research Site
      • Falls Church, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Risperidone
Drug: risperidone
flexible dose oral
Experimental: 1
Quetiapine fumarate
Drug: quetiapine fumarate
flexible dose oral
Other Names:
  • Seroquel
  • ICI 204,636

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Randomization to Month 24
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
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.
Randomization to Month 24
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
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.
Randomization to Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in the PANSS Positive Subscale Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in the PANSS Negative Subscale Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in the PANSS Psychopathology Subscale Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
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
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
Randomization to Month 24
Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
Time Frame: Randomization to Month 24
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
Randomization to Month 24
Number of Relapses of Schizophrenia or Schizoaffective Disorder
Time Frame: At Month 24
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.
At Month 24
Change in Simpson-Angus Scale (SAS) Total Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in Barnes Akathisia Rating Scale (BARS) Global Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
Time Frame: Randomization to Month 24
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.
Randomization to Month 24
Number of Participants With Potential Extrapyramidal Symptoms (EPS)
Time Frame: From start of the study treatment to last dose plus 30 days
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
From start of the study treatment to last dose plus 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5077IL/0089
  • D1441C00089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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