Schizophrenia
Conditions
Keywords
schizophrenia, medication satisfaction, Invega
Brief summary
The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of paliperidone ER (extended-release), an antipsychotic, treatment in patients with schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but who are not satisfied with their treatment.
Detailed description
Paliperidone ER has been shown to be effective compared to placebo (a sugar pill) in the acute treatment and maintenance of patients with schizophrenia. Paliperidone ER combines an active metabolite of another antipsychotic, risperidone, with manufacturing technology allowing more gradual release of the drug and less difference in high and low blood levels of the drug. Side effects to medications are sometimes due to wide differences in these high and low blood levels. Recent research has shown that many patients with schizophrenia discontinue their antipsychotic medication due to subject-choice. Therefore, it is important that research studies attempt to measure patients' satisfaction with antipsychotic medication, in addition to measuring how they respond on tests of effectiveness. This study has been designed to evaluate antipsychotic medication satisfaction in patients who continue to have symptoms of schizophrenia, and who say they are dissatisfied with their current risperidone treatment. The primary outcome is the change in the Medication Satisfaction Questionnaire (MSQ) score, from baseline to the Week 6 endpoint. These patients are randomized (like flipping a coin) as to when their risperidone (4 mg to 6 mg per day) is switched to paliperidone ER. Because the study is 'blinded', neither the study doctor nor the patient will know when treatment with risperidone is stopped and treatment with paliperidone ER begins. Throughout the study all patients continue to receive antipsychotic medication daily. Patients will continue on the same daily dose of risperidone until their randomly assigned switch to paliperidone ER. All patients will be switched to paliperidone ER over the course of study and once switched continue to take paliperidone ER for the remainder of the study. Paliperidone ER is started at 6 mg/day and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Effectiveness and safety will be measured at visits scheduled weekly for the first four weeks and then at the Week 6 endpoint. At each visit, patients will be asked to complete psychiatric tests and questionnaires that will measure effectiveness and patient satisfaction with the medicine. They will also complete tests and evaluations for safety, including electrocardiograms (ECGs, electrical tracings of the heart) and blood samples at the beginning and end of the study. Each patient receives two blinded capsules by mouth once daily in the morning for 6 weeks. Patients taking risperidone receive either a 4-mg or 6-mg capsule plus a placebo capsule. When patients are switched, Paliperidone ER is started at 6 mg/day the day after risperidone is discontinued and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Paliperidone 3-mg and 6-mg capsules are combined with placebo to equal the total dose in two capsules.
Interventions
DRUGOral Risperidone
4 or 6 mg MG once daily for 0-2 weeks
DRUGPaliperidone ER
6, 9 or 12 MG once daily for 4-6 weeks
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be able to understand, in the opinion of the investigator, the informed consent form. * be diagnosed with schizophrenia * report dissatisfaction with current medication * have an aspect of schizophrenia management which could potentially benefit from a change in antipsychotic medication * receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.
Exclusion criteria
* Unable to swallow study drug whole with the aid of water * cannot have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months * no other major mental health diagnosis except for tobacco dependance * no use of cocaine or heroin within 3 months before the first administration * no history of treatment with any antipsychotic in addition to treatment with risperidone, or treatment with paliperidone, within 30 days before the baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. | Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF) | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). | Change from Baseline in MSQ Score at Week 2 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). | Change from Baseline in MSQ Score at Week 4 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). | Change from Baseline in MSQ Score at Week 6 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Week 2 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Week 4 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Week 6 | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance. |
| Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4. |
| Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Week 6 LOCF | The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states taking all things into account, how satisfied or dissatisfied are you with this medication? and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. |
| Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100. |
| Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint | Change from Baseline to Week 6 LOCF | The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30. |
| Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint | Change from Baseline to Week 6 LOCF | 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 subject. 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 subjects. Worst value is 7 and best value is 1. |
Countries
Argentina, Colombia, Czechia, Slovakia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PALI ER Immediate Initiation Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group). | 98 |
| PALI ER Delayed Initiation Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group). | 99 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intent-to-Treat (ITT) Analysis Set | No Follow-up Efficacy Data | 3 | 3 |
| Safety Analysis Set | Did Not Receive Study Medication | 2 | 2 |
Baseline characteristics
| Characteristic | PALI ER Delayed Initiation | Total | PALI ER Immediate Initiation |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 11.4 | 40.6 years STANDARD_DEVIATION 11.9 | 41.1 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 57 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 69 Participants | 130 Participants | 61 Participants |
| Sex/Gender, Customized Female | 46 participants | 86 participants | 40 participants |
| Sex/Gender, Customized Male | 53 participants | 111 participants | 58 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 49 / 98 | 56 / 99 | 105 / 197 |
| serious Total, serious adverse events | 3 / 98 | 4 / 99 | 7 / 197 |
Outcome results
Primary
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. | 2.5 Points on a scale | Standard Deviation 1.2 |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. | 2.3 Points on a scale | Standard Deviation 1.5 |
| Overall | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. | 2.4 Points on a scale | Standard Deviation 1.4 |
Comparison: Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.p-value: <0.001t-test, 2 sided
Secondary
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Week 2
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Satisfied (score 5-7) | 63 Participants |
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Dissatisfied (score 1-4) | 30 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Satisfied (score 5-7) | 43 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Dissatisfied (score 1-4) | 52 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Satisfied (score 5-7) | 106 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). | Dissatisfied (score 1-4) | 82 Participants |
p-value: 0.002Fisher Exact
Secondary
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Week 4
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Satisfied (score 5-7) | 75 Participants |
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Dissatisfied (score 1-4) | 14 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Satisfied (score 5-7) | 64 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Dissatisfied (score 1-4) | 27 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Satisfied (score 5-7) | 139 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). | Dissatisfied (score 1-4) | 41 Participants |
p-value: 0.033Fisher Exact
Secondary
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Satisfied (score 5-7) | 83 Participants |
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Dissatisfied (score 1-4) | 12 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Dissatisfied (score 1-4) | 21 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Satisfied (score 5-7) | 75 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Dissatisfied (score 1-4) | 33 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. | Satisfied (score 5-7) | 158 Participants |
p-value: 0.125Fisher Exact
Secondary
Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Week 6
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Dissatisfied (score 1-4) | 8 Participants |
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Satisfied (score 5-7) | 77 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Satisfied (score 5-7) | 71 Participants |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Dissatisfied (score 1-4) | 16 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Satisfied (score 5-7) | 148 Participants |
| Overall | Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). | Dissatisfied (score 1-4) | 24 Participants |
p-value: 0.123Fisher Exact
Secondary
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Change from Baseline in MSQ Score at Week 2
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). | 2.0 Points on a scale | Standard Deviation 1.4 |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). | 1.6 Points on a scale | Standard Deviation 1.4 |
| Overall | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). | 1.8 Points on a scale | Standard Deviation 1.4 |
p-value: <0.001t-test, 2 sided
Secondary
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Change from Baseline in MSQ Score at Week 4
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). | 2.4 Points on a scale | Standard Deviation 1.2 |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). | 2.1 Points on a scale | Standard Deviation 1.5 |
| Overall | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). | 2.3 Points on a scale | Standard Deviation 1.4 |
p-value: <0.001t-test, 2 sided
Secondary
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).
Time frame: Change from Baseline in MSQ Score at Week 6
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). | 2.5 Points on a scale | Standard Deviation 1.2 |
| PALI ER Delayed Initiation | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). | 2.4 Points on a scale | Standard Deviation 1.3 |
| Overall | Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). | 2.5 Points on a scale | Standard Deviation 1.3 |
p-value: <0.001t-test, 2 sided
Secondary
Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint
The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint | -1.4 Points on a scale | Standard Deviation 2.8 |
| PALI ER Delayed Initiation | Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint | -1.3 Points on a scale | Standard Deviation 3.2 |
| Overall | Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint | -1.3 Points on a scale | Standard Deviation 3 |
p-value: <0.001t-test, 2 sided
Secondary
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint
The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint | -2.3 Points on a scale | Standard Deviation 4.3 |
| PALI ER Delayed Initiation | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint | -2.2 Points on a scale | Standard Deviation 4.4 |
| Overall | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint | -2.3 Points on a scale | Standard Deviation 4.3 |
p-value: <0.001t-test, 2 sided
Secondary
Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint
The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint | 6.7 Scores on a scale | Standard Deviation 10.3 |
| PALI ER Delayed Initiation | Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint | 7.2 Scores on a scale | Standard Deviation 10.6 |
| Overall | Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint | 7.0 Scores on a scale | Standard Deviation 10.4 |
p-value: <0.001t-test, 2 sided
Secondary
Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint
The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint | 0.8 Scores on a scale | Standard Deviation 8.4 |
| PALI ER Delayed Initiation | Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint | 2.1 Scores on a scale | Standard Deviation 6.4 |
| Overall | Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint | 1.5 Scores on a scale | Standard Deviation 7.5 |
p-value: 0.009t-test, 2 sided
Secondary
Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint
The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states taking all things into account, how satisfied or dissatisfied are you with this medication? and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint | 30.2 Points on a scale | Standard Deviation 22.6 |
| PALI ER Delayed Initiation | Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint | 26.4 Points on a scale | Standard Deviation 23.6 |
| Overall | Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint | 28.3 Points on a scale | Standard Deviation 23.1 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
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 subject. 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 subjects. Worst value is 7 and best value is 1.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint | -0.8 Points on a scale | Standard Deviation 0.9 |
| PALI ER Delayed Initiation | Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint | -0.8 Points on a scale | Standard Deviation 1 |
| Overall | Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint | -0.8 Points on a scale | Standard Deviation 0.9 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.
Time frame: Change from Baseline to Week 6 LOCF
Population: Intent-to-Treat Population with non-missing values at this timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PALI ER Immediate Initiation | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint | -13.5 Points on a scale | Standard Deviation 12.2 |
| PALI ER Delayed Initiation | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint | -12.3 Points on a scale | Standard Deviation 14 |
| Overall | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint | -12.9 Points on a scale | Standard Deviation 13.1 |
p-value: <0.001t-test, 2 sided