Schizophrenia
Conditions
Keywords
Schizophrenia, Risperidone, Risperdal Consta
Brief summary
The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants with a history of being poorly compliant with taking their medication.
Detailed description
This is a Phase 4, an open-label (all people know the identity of the intervention), multi-country and multi-centric (conducted in more than one center) study of risperidone long-acting formulation versus oral (having to do with the mouth) atypical antipsychotics in participants with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision ( DSM-IV TR) diagnosis of schizophrenia currently being treated with oral antipsychotic medication. The duration of this study will be 2 years. All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole and amisulpride) or to risperidone long-acting formulation. For risperidone long-acting formulation participants, study medication will be administered by intramuscular (into the muscle) injection every 2 weeks at doses of 25, 37.5 or 50 milligram (mg). Oral supplementation with the current oral atypical antipsychotic is required for the first 3 weeks following the initial injection and dose increase. Dose increase can be made as per product labeling. The primary measure of effectiveness is the reduction in the percentage of participants experiencing a clinical exacerbation after being in the study for 3 months. Participants' safety will be monitored throughout the study.
Interventions
Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.
DRUGOral atypical Antipsychotic
Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
Sponsors
Janssen-Ortho Inc., Canada
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
- Diagnosis of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2 clinical worsening of symptoms, over the past 2 years because of deteriorating adherence - Is currently receiving treatment with an antipsychotic per local product label guidelines, and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per local product label guidelines, at Baseline -Female participants must be surgically sterile, or practicing an effective method of birth control before entry and throughout the study, and have a negative urine pregnancy test at screening before study entry
Exclusion criteria
- Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia - Female participants who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start - Have a serious, unstable and untreated medical illnesses, such as vascular or cardiovascular disease, history of liver or kidney disease, significant cardiac (having to do with the heart), pulmonary (having to do with the lungs), gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic disturbances - At significant risk of suicide or violence at study start - Evidence of substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | Month 3 up to Month 24 | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Clinical Exacerbation | Baseline up to Month 24 | Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Time in Symptomatic (Having Symptoms) Remission | Baseline up to Month 24 | Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration. |
| Number of Participants With Clinical Global Impression of Change (CGI-C) | End of Study (Month 24 or Early Withdrawal [EW]) | The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Baseline and Month 24 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. |
| Percentage of Participants Who Experienced a Clinical Exacerbation | Baseline up to Month 24 | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Baseline up to Month 24 | This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study \[Visit 6, Month 24\]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone. |
| Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline and Month 24 | AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 \[worst\] to 1 \[best\] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state). |
| Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Baseline and End of Study (Month 24 or Early Termination [ET]) | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). |
| Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline and End of Study (Month 24 or Early Withdrawal [EW]) | The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening. |
Countries
Australia, Canada, Ireland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risperidone Long-Acting Injection (LAI) Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months. | 79 |
| Oral Atypical Antipsychotic Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator's discretion. | 86 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Death | 2 | 0 |
| Overall Study | End of Study (As Per Sponsor) | 12 | 24 |
| Overall Study | Investigator Withdrew Participant | 2 | 1 |
| Overall Study | Lack of Efficacy | 1 | 4 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Other | 5 | 8 |
| Overall Study | Participant Non-compliant | 3 | 6 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Started but not treated | 2 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 3 |
Baseline characteristics
| Characteristic | Risperidone Long-Acting Injection (LAI) | Oral Atypical Antipsychotic | Total |
|---|---|---|---|
| Age Continuous | 37.4 Years STANDARD_DEVIATION 12.46 | 38.9 Years STANDARD_DEVIATION 10.9 | 38.2 Years STANDARD_DEVIATION 11.67 |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 56 Participants | 63 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 70 / 81 | 69 / 86 |
| serious Total, serious adverse events | 14 / 81 | 6 / 86 |
Outcome results
Primary
Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization
Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
Time frame: Month 3 up to Month 24
Population: Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | 48.1 Percentage of participants |
| Oral Atypical Antipsychotic | Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | 43.0 Percentage of participants |
p-value: 0.5498Cox proportional hazard model
Secondary
Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24
AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 \[worst\] to 1 \[best\] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state).
Time frame: Baseline and Month 24
Population: ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Social score (n=64,66) | 0.060 Units on a scale | Standard Deviation 0.3143 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Daily activity score(n=79,83) | 0.811 Units on a scale | Standard Deviation 0.2312 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Physical score (n=79,83) | 0.872 Units on a scale | Standard Deviation 0.1437 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Illness score (n=64,67) | 0.091 Units on a scale | Standard Deviation 0.3086 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Physical score (n=64,67) | 0.065 Units on a scale | Standard Deviation 0.1581 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Daily activity score(n=64,67) | 0.051 Units on a scale | Standard Deviation 0.237 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Psychological score (n=79,83) | 0.863 Units on a scale | Standard Deviation 0.1469 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Illness score (n=79,84) | 0.396 Units on a scale | Standard Deviation 0.2496 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Psychological score (64,67) | 0.015 Units on a scale | Standard Deviation 0.1677 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Social score (n=79,83) | 0.608 Units on a scale | Standard Deviation 0.2926 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Psychological score (64,67) | 0.023 Units on a scale | Standard Deviation 0.01527 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Illness score (n=79,84) | 0.359 Units on a scale | Standard Deviation 0.2549 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Illness score (n=64,67) | 0.035 Units on a scale | Standard Deviation 0.3101 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Daily activity score(n=79,83) | 0.872 Units on a scale | Standard Deviation 0.2156 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Daily activity score(n=64,67) | -0.038 Units on a scale | Standard Deviation 0.2283 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Social score (n=64,66) | 0.025 Units on a scale | Standard Deviation 0.3474 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Physical score (n=79,83) | 0.916 Units on a scale | Standard Deviation 0.1022 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Change at Month 24: Physical score (n=64,67) | 0.020 Units on a scale | Standard Deviation 0.0919 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Psychological score (n=79,83) | 0.863 Units on a scale | Standard Deviation 0.1595 |
| Oral Atypical Antipsychotic | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline: Social score (n=79,83) | 0.613 Units on a scale | Standard Deviation 0.3117 |
Secondary
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Time frame: Baseline and End of Study (Month 24 or Early Termination [ET])
Population: ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Baseline: (n=79, 84) | 54.2 Units on a scale | Standard Error 13.32 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Change at Month 24/ET: (n=67,68) | 5.2 Units on a scale | Standard Error 17.76 |
| Oral Atypical Antipsychotic | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Baseline: (n=79, 84) | 55.0 Units on a scale | Standard Error 13.49 |
| Oral Atypical Antipsychotic | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Change at Month 24/ET: (n=67,68) | 8.4 Units on a scale | Standard Error 15.72 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
Time frame: Baseline and Month 24
Population: ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Baseline (n=79, 85) | 77.6 Units on a scale | Standard Deviation 17.24 |
| Risperidone Long-Acting Injection (LAI) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Change at Month 24: Total score (n=67, 67) | -9.6 Units on a scale | Standard Deviation 19.8 |
| Oral Atypical Antipsychotic | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Baseline (n=79, 85) | 76.5 Units on a scale | Standard Deviation 17.83 |
| Oral Atypical Antipsychotic | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Change at Month 24: Total score (n=67, 67) | -12.4 Units on a scale | Standard Deviation 21.83 |
Secondary
Number of Participants With Clinical Global Impression of Change (CGI-C)
The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.
Time frame: End of Study (Month 24 or Early Withdrawal [EW])
Population: ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Change (CGI-C) | Month 24/EW: No change or worse (n=67,68) | 19 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Change (CGI-C) | Month 24/EW:At least minimally improved(n= 67,68) | 48 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Change (CGI-C) | Month 24/EW:At least minimally improved(n= 67,68) | 38 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Change (CGI-C) | Month 24/EW: No change or worse (n=67,68) | 30 Participants |
Secondary
Number of Participants With Clinical Global Impression of Severity (CGI-S)
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Time frame: Baseline and End of Study (Month 24 or Early Withdrawal [EW])
Population: ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Month 24/EW:Moderate,marked and severe (n=67, 68) | 31 participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline: Mild or better (n=79, 85) | 18 participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline: Moderate, marked and severe (n=79, 85) | 61 participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Month 24/EW: Mild or better (n=67, 68) | 36 participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Month 24/EW: Mild or better (n=67, 68) | 39 participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Month 24/EW:Moderate,marked and severe (n=67, 68) | 29 participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline: Moderate, marked and severe (n=79, 85) | 59 participants |
| Oral Atypical Antipsychotic | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline: Mild or better (n=79, 85) | 26 participants |
Secondary
Number of Participants With Response to Resource Utilization Questionnaire (RUQ)
This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study \[Visit 6, Month 24\]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.
Time frame: Baseline up to Month 24
Population: ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Family doctor visits (total reports) | 59 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Phychiatric day care (total reports) | 19 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Emergency room visits (total reports) | 32 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Phychiatrist (total reports) | 74 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Psychologist doctor visit (total reports) | 14 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Visit by a home care nurse (total reports) | 15 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Social worker (total reports) | 43 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Psychiatric nurse (total reports) | 62 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Hospital admissions (total reports) | 42 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Suicide/crisis services (total reports) | 13 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Outpatient clinic (total reports) | 31 Participants |
| Risperidone Long-Acting Injection (LAI) | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Occupational therapist (total reports) | 28 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Outpatient clinic (total reports) | 36 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Psychologist doctor visit (total reports) | 13 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Suicide/crisis services (total reports) | 13 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Hospital admissions (total reports) | 32 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Family doctor visits (total reports) | 58 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Social worker (total reports) | 44 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Occupational therapist (total reports) | 30 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Phychiatric day care (total reports) | 13 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Phychiatrist (total reports) | 78 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Visit by a home care nurse (total reports) | 8 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Psychiatric nurse (total reports) | 58 Participants |
| Oral Atypical Antipsychotic | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Emergency room visits (total reports) | 29 Participants |
Secondary
Percentage of Participants Who Experienced a Clinical Exacerbation
Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
Time frame: Baseline up to Month 24
Population: ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Percentage of Participants Who Experienced a Clinical Exacerbation | 54.4 Percentage of participants |
| Oral Atypical Antipsychotic | Percentage of Participants Who Experienced a Clinical Exacerbation | 54.7 Percentage of participants |
Secondary
Time in Symptomatic (Having Symptoms) Remission
Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.
Time frame: Baseline up to Month 24
Population: Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan.
Secondary
Time to First Clinical Exacerbation
Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
Time frame: Baseline up to Month 24
Population: ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Risperidone Long-Acting Injection (LAI) | Time to First Clinical Exacerbation | 10.4 Months | Standard Error 0.8 |
| Oral Atypical Antipsychotic | Time to First Clinical Exacerbation | 11.2 Months | Standard Error 0.93 |