Schizophrenia
Conditions
Keywords
Schizophrenia, Drug Therapy, Treatment Outcome
Brief summary
The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The safety assessments to be conducted throughout this study including the regular monitoring and recording of all Adverse Events and Serious Adverse Events.
Detailed description
This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase
Interventions
DRUGPaliperidone
3mg or 6mg or 9mg or 12mg once daily for 52 weeks
Sponsors
Janssen-Cilag Pty Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must satisfy the following criteria to be eligible for this study: patients with diagnoses of schizophrenia according to the DSM-IV criteria including newly diagnosed patients * Out-patients or in-patients with expected discharge within 8 weeks * Patients or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
* Patients who meet any of the following criteria will be excluded from participating in the study: patients who are resistant to antipsychotic treatment * Patients who have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months * Patients with CGl-S scores \> 6 or who who have been hospitalized for longer than 8 continuous weeks during the past 6 months * Pregnant or breast-feeding females * Patients with a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Week 0 to Week 12 |
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Day 1 to Day 84 |
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Day 1 to Day 84 |
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Day 57 to Day 84 |
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Day 57 to Day 84 |
| The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Week 0 to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Global Assessment of Functioning (GAF) Throughout the Study | 52 Weeks | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. |
| The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | 52 Weeks | This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms. |
| The Number of Hospitalizations Throughout the Study | 52 Weeks | This outcome measure is intended to document all hospitalizations that occurred throughout the study. |
| The Length of Hospitalizations Throughout the Study | 52 weeks | — |
| The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 52 weeks | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Extended Release (ER) Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Ceased in favor of Paliperidone | 1 |
| Overall Study | Compliance | 3 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | No longer required | 1 |
| Overall Study | Patient was selling medication to others | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Reason not specified | 6 |
| Overall Study | Safety evaluation | 1 |
| Overall Study | Switching to trial medication | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Paliperidone Extended Release (ER) |
|---|---|
| Age Continuous | 37.0 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 64 |
| serious Total, serious adverse events | 27 / 64 |
Outcome results
Primary
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
Time frame: Day 1 to Day 84
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | 6.9 mg | Standard Deviation 2.3 |
Primary
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
Time frame: Day 57 to Day 84
Population: Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | 7.5 mg | Standard Deviation 2.4 |
Primary
The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
Time frame: Week 0 to Week 12
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | 6.8 mg | Standard Deviation 1.8 |
Primary
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
Time frame: Day 1 to Day 84
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paliperidone Extended Release (ER) | The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | 6 mg |
Primary
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
Time frame: Day 57 to Day 84
Population: Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paliperidone Extended Release (ER) | The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | 6 mg |
Primary
The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
Time frame: Week 0 to Week 12
Population: Intent-To-Treat (ITT) population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paliperidone Extended Release (ER) | The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | 6 mg |
Secondary
The Clinical Global Impression of Severity (CGI-S) Throughout the Study
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients.
Time frame: 52 weeks
Population: All participants with evaluable data at each measurement time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 3.7 scores on a scale | Standard Deviation 1.2 |
| Week 2 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 3.3 scores on a scale | Standard Deviation 1.1 |
| Week 4 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 3.2 scores on a scale | Standard Deviation 1 |
| Week 6 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 3.1 scores on a scale | Standard Deviation 1.1 |
| Week 9 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.8 scores on a scale | Standard Deviation 1 |
| Week 12 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.8 scores on a scale | Standard Deviation 1 |
| Week 20 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.9 scores on a scale | Standard Deviation 1.1 |
| Week 28 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.7 scores on a scale | Standard Deviation 1.1 |
| Week 36 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.7 scores on a scale | Standard Deviation 0.8 |
| Week 44 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.9 scores on a scale | Standard Deviation 1.2 |
| Week 52 | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 2.7 scores on a scale | Standard Deviation 0.8 |
Secondary
The Global Assessment of Functioning (GAF) Throughout the Study
The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Time frame: 52 Weeks
Population: All participants with evaluable data at each measurement time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Global Assessment of Functioning (GAF) Throughout the Study | 54.6 scores on a scale | Standard Deviation 14.7 |
| Week 2 | The Global Assessment of Functioning (GAF) Throughout the Study | 58.9 scores on a scale | Standard Deviation 15 |
| Week 4 | The Global Assessment of Functioning (GAF) Throughout the Study | 63.9 scores on a scale | Standard Deviation 15.3 |
| Week 6 | The Global Assessment of Functioning (GAF) Throughout the Study | 63.9 scores on a scale | Standard Deviation 15.6 |
| Week 9 | The Global Assessment of Functioning (GAF) Throughout the Study | 66.3 scores on a scale | Standard Deviation 13.8 |
| Week 12 | The Global Assessment of Functioning (GAF) Throughout the Study | 65.4 scores on a scale | Standard Deviation 14.6 |
| Week 20 | The Global Assessment of Functioning (GAF) Throughout the Study | 65.1 scores on a scale | Standard Deviation 14.7 |
| Week 28 | The Global Assessment of Functioning (GAF) Throughout the Study | 71.1 scores on a scale | Standard Deviation 13.3 |
| Week 36 | The Global Assessment of Functioning (GAF) Throughout the Study | 71.6 scores on a scale | Standard Deviation 14.9 |
| Week 44 | The Global Assessment of Functioning (GAF) Throughout the Study | 69.0 scores on a scale | Standard Deviation 17.2 |
| Week 52 | The Global Assessment of Functioning (GAF) Throughout the Study | 63.3 scores on a scale | Standard Deviation 15.7 |
Secondary
The Length of Hospitalizations Throughout the Study
Time frame: 52 weeks
Population: Participants who were hospitalized and had evaluable data at each measurement time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Length of Hospitalizations Throughout the Study | 12.4 days | Standard Deviation 11.5 |
| Week 2 | The Length of Hospitalizations Throughout the Study | 66 days | Standard Deviation 0 |
| Week 4 | The Length of Hospitalizations Throughout the Study | 7.3 days | Standard Deviation 6 |
| Week 6 | The Length of Hospitalizations Throughout the Study | 28.0 days | Standard Deviation 5.7 |
| Week 9 | The Length of Hospitalizations Throughout the Study | 179.0 days | Standard Deviation 220.6 |
| Week 12 | The Length of Hospitalizations Throughout the Study | 34 days | Standard Deviation 0 |
| Week 20 | The Length of Hospitalizations Throughout the Study | 19 days | Standard Deviation 0 |
| Week 28 | The Length of Hospitalizations Throughout the Study | 4 days | Standard Deviation 0 |
| Week 36 | The Length of Hospitalizations Throughout the Study | 20.5 days | Standard Deviation 10.6 |
Secondary
The Number of Hospitalizations Throughout the Study
This outcome measure is intended to document all hospitalizations that occurred throughout the study.
Time frame: 52 Weeks
Population: All participants with evaluable data at each measurement time point
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) | The Number of Hospitalizations Throughout the Study | 15 events | 14.7 |
| Week 2 | The Number of Hospitalizations Throughout the Study | 2 events | 15 |
| Week 4 | The Number of Hospitalizations Throughout the Study | 6 events | 15.3 |
| Week 6 | The Number of Hospitalizations Throughout the Study | 2 events | 15.6 |
| Week 9 | The Number of Hospitalizations Throughout the Study | 3 events | 13.8 |
| Week 12 | The Number of Hospitalizations Throughout the Study | 1 events | 14.6 |
| Week 20 | The Number of Hospitalizations Throughout the Study | 1 events | 14.7 |
| Week 28 | The Number of Hospitalizations Throughout the Study | 0 events | 13.3 |
| Week 36 | The Number of Hospitalizations Throughout the Study | 0 events | 14.9 |
| Week 44 | The Number of Hospitalizations Throughout the Study | 1 events | 17.2 |
| Week 52 | The Number of Hospitalizations Throughout the Study | 2 events | 15.7 |
Secondary
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.
Time frame: 52 Weeks
Population: All participants with evaluable data at each measurement time point
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 0 percentage of participants | — |
| Paliperidone Extended Release (ER) | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Paliperidone Extended Release (ER) | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 0 percentage of participants | 14.7 |
| Paliperidone Extended Release (ER) | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Paliperidone Extended Release (ER) | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 4.8 percentage of participants | — |
| Week 2 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 2 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 0 percentage of participants | — |
| Week 2 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 5.3 percentage of participants | 15 |
| Week 2 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 5.3 percentage of participants | — |
| Week 2 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 4 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 5.4 percentage of participants | — |
| Week 4 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 8.1 percentage of participants | — |
| Week 4 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 4 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 13.5 percentage of participants | 15.3 |
| Week 4 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 6 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 6 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 5.9 percentage of participants | 15.6 |
| Week 6 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 6 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 6 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 2.9 percentage of participants | — |
| Week 9 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 9 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 9 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 3.6 percentage of participants | — |
| Week 9 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 7.1 percentage of participants | 13.8 |
| Week 9 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 12 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 12 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 12 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 3.2 percentage of participants | 14.6 |
| Week 12 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 3.2 percentage of participants | — |
| Week 12 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 3.2 percentage of participants | — |
| Week 20 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 20 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 3.7 percentage of participants | 14.7 |
| Week 20 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 7.4 percentage of participants | — |
| Week 20 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 20 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 28 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 28 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 0 percentage of participants | 13.3 |
| Week 28 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 0 percentage of participants | — |
| Week 28 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 28 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 36 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 36 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 36 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 36 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 0 percentage of participants | 14.9 |
| Week 36 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 0 percentage of participants | — |
| Week 44 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 44 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 44 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 0 percentage of participants | 17.2 |
| Week 44 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 44 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 5.9 percentage of participants | — |
| Week 52 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Self Injury | 0 percentage of participants | — |
| Week 52 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Care Increase | 12.5 percentage of participants | — |
| Week 52 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Violent | 0 percentage of participants | — |
| Week 52 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Suicidal | 0 percentage of participants | — |
| Week 52 | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | Hospitalized | 12.5 percentage of participants | 15.7 |