Clinical trial NCT00206102: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1098
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Randomization to Month 24
measure: 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
timeFrame: Randomization to Month 24
measure: 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
timeFrame: Randomization to Month 24
Secondary outcomes:
measure: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Randomization to Month 24
measure: Change in the PANSS Positive Subscale Score
timeFrame: Randomization to Month 24
measure: Change in the PANSS Negative Subscale Score
timeFrame: Randomization to Month 24
measure: Change in the PANSS Psychopathology Subscale Score
timeFrame: Randomization to Month 24
measure: Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
timeFrame: Randomization to Month 24
measure: 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
timeFrame: Randomization to Month 24
measure: Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
timeFrame: Randomization to Month 24
measure: Number of Relapses of Schizophrenia or Schizoaffective Disorder
timeFrame: At Month 24
measure: Change in Simpson-Angus Scale (SAS) Total Score
timeFrame: Randomization to Month 24
measure: Change in Barnes Akathisia Rating Scale (BARS) Global Score
timeFrame: Randomization to Month 24
measure: Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: Randomization to Month 24
measure: Number of Participants With Potential Extrapyramidal Symptoms (EPS)
timeFrame: From start of the study treatment to last dose plus 30 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Mabelvale
country: United States
facility: Research Site
state: Arkansas
city: Morrilton
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Marcos
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: New Britian
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Deerfield Beach
country: United States
facility: Research Site
state: Florida
city: Ft Lauderdale
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Pompano Beach
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: W. Palm Beach
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Joliet
country: United States
facility: Research Site
state: Illinois
city: Oak Brook Terrace
country: United States
facility: Research Site
state: Illinois
city: Schaumburg
country: United States
facility: Research Site
state: Illinois
city: Newton
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Moorestown
country: United States
facility: Research Site
state: New Jersey
city: Paramus
country: United States
facility: Research Site
state: New Jersey
city: Stratford
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Beechwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Lyndhurst
country: United States
facility: Research Site
state: Ohio
city: Medina
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Media
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Midvale
country: United States
facility: Research Site
state: Utah
city: Arlington
country: United States
facility: Research Site
state: Virginia
city: Falls Church
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References: