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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206102
• Other study ID #: 5077IL/0089
• Secondary ID: D1441C00089
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: January 8, 2013
• Start date: September 2003
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1098
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• quetiapine fumarate
flexible dose oral
• risperidone
flexible dose oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Randomization to Month 24	No
Primary	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.	Randomization to Month 24	No
Primary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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	Randomization to Month 24	No
Secondary	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	Randomization to Month 24	No
Secondary	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.	At Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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.	Randomization to Month 24	No
Secondary	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	From start of the study treatment to last dose plus 30 days	No