Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder
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.
Interventions
DRUGquetiapine fumarate
flexible dose oral
DRUGrisperidone
flexible dose oral
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the PANSS Psychopathology Subscale Score | 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. |
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | 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. |
| 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 | 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 |
| Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | 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 |
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | 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. |
| Change in Simpson-Angus Scale (SAS) Total Score | 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. |
| Change in Barnes Akathisia Rating Scale (BARS) Global Score | 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. |
| Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | 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. |
| Number of Participants With Potential Extrapyramidal Symptoms (EPS) | 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 |
| Number of Relapses of Schizophrenia or Schizoaffective Disorder | 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. |
| Change in the PANSS Positive Subscale Score | 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. |
| Change in the PANSS Negative Subscale Score | 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. |
Countries
United States
Participant flow
Recruitment details
A 24-month, multi-center, evaluator masked (ophthalmologist), open-label, flexible-dose, parallel-group study, 82 sites recruited Sept 2003 through Oct 2008. In total 1099 participants were randomized by Interactive Voice Response System (IVRS). One excluded participant was randomized before the rand visit, and never returned to any study visits.
Pre-assignment details
Screening for eligibility and must be cross-tapered off of all previous antipsychotic medications
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine Fumarate Quetiapine fumarate - flexibly dosed (200 - 800 mg/day) | 596 |
| Risperidone Risperidone - flexibly dosed (2 - 8 mg/day) | 502 |
| Total | 1,098 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 119 | 82 |
| Overall Study | Lack of therapeutic response | 16 | 11 |
| Overall Study | Lost to Follow-up | 95 | 66 |
| Overall Study | None of those categories | 42 | 36 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Study-specific discontinuation criteria | 18 | 17 |
| Overall Study | Withdrawal by Subject | 118 | 101 |
Baseline characteristics
| Characteristic | Quetiapine Fumarate | Risperidone | Total |
|---|---|---|---|
| Age, Customized 40 to 65 years | 331 Participants | 279 Participants | 610 Participants |
| Age, Customized < 40 years | 265 Participants | 223 Participants | 488 Participants |
| Sex: Female, Male Female | 253 Participants | 199 Participants | 452 Participants |
| Sex: Female, Male Male | 343 Participants | 303 Participants | 646 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 476 / 596 | 368 / 502 |
| serious Total, serious adverse events | 151 / 596 | 114 / 502 |
Outcome results
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.
Time frame: Randomization to Month 24
Population: The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Fumarate | 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 | 2 Participants with C type event |
| Risperidone | 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 | 8 Participants with C type event |
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.
Time frame: Randomization to Month 24
Population: The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Fumarate | 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 | 0 Participants with N type event |
| Risperidone | 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 | 2 Participants with N type event |
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.
Time frame: Randomization to Month 24
Population: The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Fumarate | 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 | 4 Participants with P type event |
| Risperidone | 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 | 7 Participants with P type event |
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.
Time frame: Randomization to Month 24
Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | -0.2 units on scale | Standard Deviation 2.5 |
| Risperidone | Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | 0.1 units on scale | Standard Deviation 2.5 |
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.
Time frame: Randomization to Month 24
Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in Barnes Akathisia Rating Scale (BARS) Global Score | -0.1 units of scale | Standard Deviation 0.7 |
| Risperidone | Change in Barnes Akathisia Rating Scale (BARS) Global Score | 0.1 units of scale | Standard Deviation 0.8 |
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
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | 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 | 2.4 units on scale | Standard Deviation 11.6 |
| Risperidone | 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 | 2.7 units on scale | Standard Deviation 10.4 |
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
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | 1.2 units on scale | Standard Deviation 6.2 |
| Risperidone | Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | 0.9 units on scale | Standard Deviation 6 |
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.
Time frame: Randomization to Month 24
Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in Simpson-Angus Scale (SAS) Total Score | -0.7 units on scale | Standard Deviation 2.1 |
| Risperidone | Change in Simpson-Angus Scale (SAS) Total Score | -0.4 units on scale | Standard Deviation 2.8 |
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.
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | -0.7 units on scale | Standard Deviation 0.9 |
| Risperidone | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | -0.5 units on scale | Standard Deviation 1 |
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.
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in the PANSS Negative Subscale Score | -2.2 units on scale | Standard Deviation 5.5 |
| Risperidone | Change in the PANSS Negative Subscale Score | -1.5 units on scale | Standard Deviation 5.7 |
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.
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in the PANSS Positive Subscale Score | -2.7 units on scale | Standard Deviation 5.3 |
| Risperidone | Change in the PANSS Positive Subscale Score | -2.8 units on scale | Standard Deviation 5.1 |
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.
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in the PANSS Psychopathology Subscale Score | -4.2 units on scale | Standard Deviation 7.7 |
| Risperidone | Change in the PANSS Psychopathology Subscale Score | -4.4 units on scale | Standard Deviation 8.8 |
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.
Time frame: Randomization to Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine Fumarate | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | -9.1 units on scale | Standard Deviation 15.4 |
| Risperidone | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | -8.6 units on scale | Standard Deviation 16.6 |
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
Time frame: From start of the study treatment to last dose plus 30 days
Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Fumarate | Number of Participants With Potential Extrapyramidal Symptoms (EPS) | 73 Participants |
| Risperidone | Number of Participants With Potential Extrapyramidal Symptoms (EPS) | 106 Participants |
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.
Time frame: At Month 24
Population: The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Fumarate | Number of Relapses of Schizophrenia or Schizoaffective Disorder | 24 Relapses |
| Risperidone | Number of Relapses of Schizophrenia or Schizoaffective Disorder | 33 Relapses |