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Trial record 1 of 1 for:    quetiapine and risperidone and cataracts
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A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00206102
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : July 13, 2011
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: quetiapine fumarate Drug: risperidone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1098 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Quetiapine fumarate
 Drug: quetiapine fumarate
flexible dose oral
Other Names:
  • Seroquel
  • ICI 204,636
Active Comparator: 2
Risperidone
 Drug: risperidone
flexible dose oral


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206102


Locations
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United States, Arkansas
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Little Rock, Arkansas, United States
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Mabelvale, Arkansas, United States
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Morrilton, Arkansas, United States
United States, California
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Anaheim, California, United States
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Cerritos, California, United States
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Chula Vista, California, United States
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Garden Grove, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Diego, California, United States
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San Marcos, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Connecticut
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New Britian, Connecticut, United States
United States, Florida
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Deerfield Beach, Florida, United States
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Ft Lauderdale, Florida, United States
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Pompano Beach, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Joliet, Illinois, United States
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Oak Brook Terrace, Illinois, United States
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Schaumburg, Illinois, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Glen Burnie, Maryland, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Moorestown, New Jersey, United States
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Paramus, New Jersey, United States
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Stratford, New Jersey, United States
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Staten Island, New York, United States
United States, Ohio
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Beechwood, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Lyndhurst, Ohio, United States
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Medina, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
United States, Utah
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Midvale, Utah, United States
United States, Virginia
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Arlington, Virginia, United States
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Falls Church, Virginia, United States
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Richmond, Virginia, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00206102    
Other Study ID Numbers: 5077IL/0089
D1441C00089
First Posted: September 21, 2005    Key Record Dates
Results First Posted: July 13, 2011
Last Update Posted: January 14, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective Disorder
Additional relevant MeSH terms:
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Risperidone
Quetiapine Fumarate
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents