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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
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: quetiapine fumarate
Drug: risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Randomization to Month 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: From start of the study treatment to last dose plus 30 days ] [ Designated as safety issue: No ]
    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


Enrollment: 1098
Study Start Date: September 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206102

  Show 64 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:
Risperidone
Quetiapine
Schizophrenia
Disease
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 15, 2014