Schizophrenia
Conditions
Keywords
schizophrenia, acute exacerbation, inpatient
Brief summary
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.
Interventions
DRUGPF-02545920
5 mg tablet every 12 hours for 28 days
DRUGPlacebo
One tablet/capsule every 12 hours for 28 days
DRUGRisperidone
3 mg capsule every 12 hours for 28 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia with acute exacerbation of illness * The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.
Exclusion criteria
* Subjects with evidence or history of clinically significant uncontrolled medical illness * Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder. * Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Baseline, Week 4 | PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. |
| Proportion of Participants With Dystonia Adverse Events | Baseline up to end of study (7 to 10 days after administration of last dose of study medication) | Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline, Week 4 | PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Baseline, Week 4 | PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity. |
| Clinical Global Impression - Improvement (CGI-I) Score | Week 4 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed? Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. |
| Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Baseline, Week 4 | GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor. |
| Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Week 4 | TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction. |
| Change From Baseline in Body Weight at Week 4 | Baseline, Week 4 | — |
| Change From Baseline in Abdominal Girth at Week 4 | Baseline, Week 4 | — |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline, Week 4 | PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity. |
| Number of Participants With Clinically Significant Changes in Physical Examinations | Screening, Week 4 | Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed. |
| Number of Participants With Laboratory Test Abnormalities | Screening up to end of study (7 to 10 days after administration of last dose of study medication) | Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN) |
| Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | Day 1 up to Week 4 | Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal. |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin | Day 1 up to Week 4 | Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein \[HDL\], low-density lipoprotein \[LDL\], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c \[HbA1c\] and Prolactin). |
| Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline, Week 4 | ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected. |
| Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 | Baseline, Week 4 | MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S \* D \* C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 \[mild\]; 2 \[moderate\]; 3 \[severe\]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline. |
| Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication) | Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement. |
| Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) | Baseline up to end of study (7 to 10 days after administration of last dose of study medication) | Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction \[QTcB\] interval, and QT corrected using Fridericia's correction \[QTcF\]). |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Baseline, Week 4 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected. |
Countries
Germany, Ukraine, United States
Participant flow
Pre-assignment details
Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 2 days during the placebo lead-in phase (before randomization in the study).
Participants by arm
| Arm | Count |
|---|---|
| PF-02545920 5 mg Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days. | 74 |
| PF-02545920 15 mg Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days. | 74 |
| Risperidone 3 mg Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days. | 36 |
| Placebo Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days. | 74 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 | 3 | 4 |
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 4 | 5 | 0 | 5 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Overall Study | Other | 3 | 1 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Randomized But Not Treated | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 8 | 5 | 5 |
Baseline characteristics
| Characteristic | PF-02545920 5 mg | PF-02545920 15 mg | Risperidone 3 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 11.2 | 41.7 years STANDARD_DEVIATION 10.5 | 41.3 years STANDARD_DEVIATION 10.9 | 41.2 years STANDARD_DEVIATION 10.9 | 41.9 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 11 Participants | 18 Participants | 60 Participants |
| Sex: Female, Male Male | 57 Participants | 60 Participants | 25 Participants | 56 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 53 / 74 | 47 / 74 | 22 / 36 | 51 / 74 |
| serious Total, serious adverse events | 3 / 74 | 6 / 74 | 2 / 36 | 1 / 74 |
Outcome results
Primary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time frame: Baseline, Week 4
Population: Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Baseline | 98.1 units on a scale | Standard Deviation 11.81 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change at Week 4 | -15.3 units on a scale | Standard Deviation 15.56 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change at Week 4 | -13.8 units on a scale | Standard Deviation 17.93 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Baseline | 97.7 units on a scale | Standard Deviation 11.14 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change at Week 4 | -17.9 units on a scale | Standard Deviation 10.99 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Baseline | 97.4 units on a scale | Standard Deviation 15.05 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change at Week 4 | -12.6 units on a scale | Standard Deviation 15.29 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Baseline | 97.2 units on a scale | Standard Deviation 14.92 |
Comparison: Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.205380% CI: [-5.66, 1.24]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.402480% CI: [-4.14, 2.8]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.00980% CI: [-12.68, -3.8]Mixed Models Analysis
Primary
Proportion of Participants With Dystonia Adverse Events
Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.
Time frame: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 5 mg | Proportion of Participants With Dystonia Adverse Events | 0.01 proportion of participants |
| PF-02545920 15 mg | Proportion of Participants With Dystonia Adverse Events | 0.08 proportion of participants |
| Risperidone 3 mg | Proportion of Participants With Dystonia Adverse Events | 0.00 proportion of participants |
| Placebo | Proportion of Participants With Dystonia Adverse Events | 0.04 proportion of participants |
80% CI: [-0.07, 0.01]
80% CI: [-0.02, 0.1]
80% CI: [-0.08, 0]
Secondary
Change From Baseline in Abdominal Girth at Week 4
Time frame: Baseline, Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Abdominal Girth at Week 4 | Change at Week 4 | 0.71 centimeter (cm) | Standard Deviation 5.07 |
| PF-02545920 5 mg | Change From Baseline in Abdominal Girth at Week 4 | Baseline | 96.5 centimeter (cm) | Standard Deviation 12.33 |
| PF-02545920 15 mg | Change From Baseline in Abdominal Girth at Week 4 | Change at Week 4 | 0.70 centimeter (cm) | Standard Deviation 5.73 |
| PF-02545920 15 mg | Change From Baseline in Abdominal Girth at Week 4 | Baseline | 97.2 centimeter (cm) | Standard Deviation 13.49 |
| Risperidone 3 mg | Change From Baseline in Abdominal Girth at Week 4 | Baseline | 95.6 centimeter (cm) | Standard Deviation 13.58 |
| Risperidone 3 mg | Change From Baseline in Abdominal Girth at Week 4 | Change at Week 4 | 3.33 centimeter (cm) | Standard Deviation 4.54 |
| Placebo | Change From Baseline in Abdominal Girth at Week 4 | Change at Week 4 | 0.74 centimeter (cm) | Standard Deviation 4.29 |
| Placebo | Change From Baseline in Abdominal Girth at Week 4 | Baseline | 93.5 centimeter (cm) | Standard Deviation 16.05 |
Secondary
Change From Baseline in Body Weight at Week 4
Time frame: Baseline, Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Body Weight at Week 4 | Baseline | 86.1 kilogram (kg) | Standard Deviation 15.06 |
| PF-02545920 5 mg | Change From Baseline in Body Weight at Week 4 | Change at Week 4 | 0.18 kilogram (kg) | Standard Deviation 2.23 |
| PF-02545920 15 mg | Change From Baseline in Body Weight at Week 4 | Change at Week 4 | -1.23 kilogram (kg) | Standard Deviation 3.18 |
| PF-02545920 15 mg | Change From Baseline in Body Weight at Week 4 | Baseline | 87.5 kilogram (kg) | Standard Deviation 14.46 |
| Risperidone 3 mg | Change From Baseline in Body Weight at Week 4 | Baseline | 83.9 kilogram (kg) | Standard Deviation 16.99 |
| Risperidone 3 mg | Change From Baseline in Body Weight at Week 4 | Change at Week 4 | 2.69 kilogram (kg) | Standard Deviation 3 |
| Placebo | Change From Baseline in Body Weight at Week 4 | Baseline | 84.3 kilogram (kg) | Standard Deviation 19.31 |
| Placebo | Change From Baseline in Body Weight at Week 4 | Change at Week 4 | 1.04 kilogram (kg) | Standard Deviation 2.61 |
Secondary
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.
Time frame: Baseline, Week 4
Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Baseline | 5.0 units on a scale | Standard Deviation 0.56 |
| PF-02545920 5 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Change at Week 4 | -0.7 units on a scale | Standard Deviation 0.87 |
| PF-02545920 15 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Change at Week 4 | -0.7 units on a scale | Standard Deviation 1.06 |
| PF-02545920 15 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Baseline | 5.0 units on a scale | Standard Deviation 0.49 |
| Risperidone 3 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Change at Week 4 | -0.8 units on a scale | Standard Deviation 0.78 |
| Risperidone 3 mg | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Baseline | 4.9 units on a scale | Standard Deviation 0.67 |
| Placebo | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Baseline | 5.0 units on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 | Change at Week 4 | -0.6 units on a scale | Standard Deviation 0.92 |
Comparison: MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.19780% CI: [-0.33, 0.07]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.383580% CI: [-0.24, 0.15]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.039580% CI: [-0.61, -0.1]Mixed Models Analysis
Secondary
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4
ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.
Time frame: Baseline, Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dyskinesia | 0.122 units on a scale | Standard Deviation 0.4038 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Parkinsonism | 0.257 units on a scale | Standard Deviation 1.0476 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dystonia | 0.095 units on a scale | Standard Deviation 0.5278 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Akathisia | 0.162 units on a scale | Standard Deviation 0.5496 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Parkinsonism | 0.143 units on a scale | Standard Deviation 0.8397 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dystonia | 0.000 units on a scale | Standard Deviation 0.4016 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dyskinesia | 0.016 units on a scale | Standard Deviation 0.4916 |
| PF-02545920 5 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Akathisia | 0.032 units on a scale | Standard Deviation 0.6713 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dystonia | 0.207 units on a scale | Standard Deviation 1.1044 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Parkinsonism | 0.086 units on a scale | Standard Deviation 1.3414 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dystonia | 0.000 units on a scale | Standard Deviation 0 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Akathisia | 0.328 units on a scale | Standard Deviation 1.3297 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Parkinsonism | 0.500 units on a scale | Standard Deviation 1.5283 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Akathisia | 0.068 units on a scale | Standard Deviation 0.4778 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dyskinesia | 0.095 units on a scale | Standard Deviation 0.4432 |
| PF-02545920 15 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dyskinesia | 0.207 units on a scale | Standard Deviation 1.0884 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dystonia | 0.000 units on a scale | Standard Deviation 0 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dyskinesia | 0.194 units on a scale | Standard Deviation 0.5767 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Akathisia | 0.111 units on a scale | Standard Deviation 0.6667 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Parkinsonism | -0.038 units on a scale | Standard Deviation 0.9157 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dystonia | 0.000 units on a scale | Standard Deviation 0 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Akathisia | 0.154 units on a scale | Standard Deviation 1.2866 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Parkinsonism | 0.194 units on a scale | Standard Deviation 0.6242 |
| Risperidone 3 mg | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dyskinesia | 0.038 units on a scale | Standard Deviation 0.4455 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dystonia | 0.027 units on a scale | Standard Deviation 0.1633 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Akathisia | 0.243 units on a scale | Standard Deviation 0.7551 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dyskinesia | -0.032 units on a scale | Standard Deviation 0.3578 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Dyskinesia | 0.135 units on a scale | Standard Deviation 0.5054 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Parkinsonism | -0.190 units on a scale | Standard Deviation 1.4126 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Akathisia | -0.095 units on a scale | Standard Deviation 0.9283 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Baseline: Parkinsonism | 0.473 units on a scale | Standard Deviation 1.5809 |
| Placebo | Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 | Change at Week 4: Dystonia | 0.032 units on a scale | Standard Deviation 0.252 |
Secondary
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4
GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.
Time frame: Baseline, Week 4
Population: FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Baseline | 38.4 units on a scale | Standard Deviation 8.31 |
| PF-02545920 5 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Change at Week 4 | 6.3 units on a scale | Standard Deviation 9.08 |
| PF-02545920 15 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Change at Week 4 | 6.9 units on a scale | Standard Deviation 8.92 |
| PF-02545920 15 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Baseline | 38.5 units on a scale | Standard Deviation 7.82 |
| Risperidone 3 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Baseline | 38.7 units on a scale | Standard Deviation 10.58 |
| Risperidone 3 mg | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Change at Week 4 | 7.7 units on a scale | Standard Deviation 8.45 |
| Placebo | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Baseline | 38.2 units on a scale | Standard Deviation 8.78 |
| Placebo | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 | Change at Week 4 | 6.3 units on a scale | Standard Deviation 8.14 |
Comparison: MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.542980% CI: [-2.06, 1.74]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.435480% CI: [-1.68, 2.16]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.09380% CI: [0.08, 4.99]Mixed Models Analysis
Secondary
Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4
MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S \* D \* C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 \[mild\]; 2 \[moderate\]; 3 \[severe\]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.
Time frame: Baseline, Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 | 0.0019 units on a scale | Standard Deviation 0.01648 |
| PF-02545920 15 mg | Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 | 0.0163 units on a scale | Standard Deviation 0.08087 |
| Risperidone 3 mg | Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 | 0.0000 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 | 0.0126 units on a scale | Standard Deviation 0.10349 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4
PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.
Time frame: Baseline, Week 4
Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Baseline | 17.4 units on a scale | Standard Deviation 2.74 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Change at Week 4 | -3.7 units on a scale | Standard Deviation 3.39 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Change at Week 4 | -3.4 units on a scale | Standard Deviation 3.75 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Baseline | 17.3 units on a scale | Standard Deviation 2.32 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Baseline | 17.2 units on a scale | Standard Deviation 2.77 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Change at Week 4 | -4.7 units on a scale | Standard Deviation 2.99 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Baseline | 17.3 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 | Change at Week 4 | -3.2 units on a scale | Standard Deviation 3.12 |
Comparison: MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.272780% CI: [-1.06, 0.38]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.474780% CI: [-0.76, 0.69]Mixed Models Analysis
Comparison: MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.003180% CI: [-2.93, -1.07]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4
PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.
Time frame: Baseline, Week 4
Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Positive score | 30.9 units on a scale | Standard Deviation 4.51 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Negative Score | 23.0 units on a scale | Standard Deviation 4.43 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Dis. Thought Score | 20.4 units on a scale | Standard Deviation 5.13 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Uncon. Hos/Exc Score | 10.4 units on a scale | Standard Deviation 2.92 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Anx/Dep Score | 13.5 units on a scale | Standard Deviation 2.81 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Positive score | -5.5 units on a scale | Standard Deviation 5.34 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Negative Score | -3.0 units on a scale | Standard Deviation 4.99 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Dis. Thought Score | -2.5 units on a scale | Standard Deviation 3.47 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Uncon.Hos/ExcScore | -1.2 units on a scale | Standard Deviation 3.31 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Anx/DepScore | -2.9 units on a scale | Standard Deviation 3.72 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Dis. Thought Score | 21.0 units on a scale | Standard Deviation 4.37 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Uncon.Hos/ExcScore | -0.9 units on a scale | Standard Deviation 3.12 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Uncon. Hos/Exc Score | 9.8 units on a scale | Standard Deviation 2.98 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Anx/Dep Score | 13.0 units on a scale | Standard Deviation 3.16 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Positive score | -5.0 units on a scale | Standard Deviation 5.56 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Negative Score | -2.9 units on a scale | Standard Deviation 5.69 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Anx/DepScore | -2.6 units on a scale | Standard Deviation 3.85 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Dis. Thought Score | -2.3 units on a scale | Standard Deviation 4.39 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Positive score | 30.6 units on a scale | Standard Deviation 4.12 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Negative Score | 23.3 units on a scale | Standard Deviation 4.99 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Dis. Thought Score | -3.0 units on a scale | Standard Deviation 3.06 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Negative Score | -2.5 units on a scale | Standard Deviation 4.44 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Anx/DepScore | -3.8 units on a scale | Standard Deviation 3.31 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Positive score | 30.3 units on a scale | Standard Deviation 5.45 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Uncon. Hos/Exc Score | 10.6 units on a scale | Standard Deviation 3.97 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Positive score | -6.2 units on a scale | Standard Deviation 4.53 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Uncon.Hos/ExcScore | -2.4 units on a scale | Standard Deviation 2.28 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Negative Score | 22.9 units on a scale | Standard Deviation 5.04 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Anx/Dep Score | 12.4 units on a scale | Standard Deviation 3.17 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Dis. Thought Score | 21.3 units on a scale | Standard Deviation 5.49 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Anx/Dep Score | 12.9 units on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Dis. Thought Score | -1.9 units on a scale | Standard Deviation 3.05 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Positive score | -4.6 units on a scale | Standard Deviation 5 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Anx/DepScore | -2.9 units on a scale | Standard Deviation 3.22 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4: Negative Score | -2.3 units on a scale | Standard Deviation 4.91 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Negative Score | 23.0 units on a scale | Standard Deviation 5.06 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Dis. Thought Score | 20.3 units on a scale | Standard Deviation 5.7 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Uncon. Hos/Exc Score | 10.0 units on a scale | Standard Deviation 3.44 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Baseline: Positive score | 31.0 units on a scale | Standard Deviation 4.68 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 | Change at Week 4:Uncon.Hos/ExcScore | -1.0 units on a scale | Standard Deviation 2.95 |
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.199980% CI: [-1.84, 0.38]Mixed Models Analysis
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.339980% CI: [-1.48, 0.76]Mixed Models Analysis
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.0180% CI: [-4.06, -1.18]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.162580% CI: [-1.77, 0.23]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.235480% CI: [-1.57, 0.44]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.216180% CI: [-2.08, 0.5]Mixed Models Analysis
Comparison: Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.24880% CI: [-1.23, 0.38]Mixed Models Analysis
Comparison: Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.434580% CI: [-0.92, 0.71]Mixed Models Analysis
Comparison: Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.034680% CI: [-2.53, -0.44]Mixed Models Analysis
Comparison: Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.468580% CI: [-0.68, 0.6]Mixed Models Analysis
Comparison: Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.621480% CI: [-0.49, 0.8]Mixed Models Analysis
Comparison: Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.005280% CI: [-2.48, -0.84]Mixed Models Analysis
Comparison: Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.589480% CI: [-0.55, 0.79]Mixed Models Analysis
Comparison: Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.815580% CI: [-0.2, 1.15]Mixed Models Analysis
Comparison: Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.006980% CI: [-2.55, -0.81]Mixed Models Analysis
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4
PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.
Time frame: Baseline, Week 4
Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: General Score | 47.9 units on a scale | Standard Deviation 6.67 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Positive Score | 26.9 units on a scale | Standard Deviation 4 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Positive Score | -5.0 units on a scale | Standard Deviation 5.26 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: General Score | -7.5 units on a scale | Standard Deviation 7.75 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Negative Score | -2.7 units on a scale | Standard Deviation 4.62 |
| PF-02545920 5 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Negative Score | 23.4 units on a scale | Standard Deviation 4.15 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Negative Score | -2.2 units on a scale | Standard Deviation 5.09 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: General Score | 48.2 units on a scale | Standard Deviation 6.43 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: General Score | -7.1 units on a scale | Standard Deviation 8.8 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Positive Score | 26.1 units on a scale | Standard Deviation 3.89 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Negative Score | 23.4 units on a scale | Standard Deviation 4.32 |
| PF-02545920 15 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Positive Score | -4.5 units on a scale | Standard Deviation 5.51 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: General Score | -8.6 units on a scale | Standard Deviation 5.85 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Negative Score | -2.7 units on a scale | Standard Deviation 4.03 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Positive Score | -6.7 units on a scale | Standard Deviation 3.84 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Negative Score | 24.0 units on a scale | Standard Deviation 5.18 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: General Score | 46.8 units on a scale | Standard Deviation 8.25 |
| Risperidone 3 mg | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Positive Score | 26.6 units on a scale | Standard Deviation 4.74 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: General Score | -6.6 units on a scale | Standard Deviation 8.2 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Negative Score | 23.2 units on a scale | Standard Deviation 5.12 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: General Score | 47.2 units on a scale | Standard Deviation 7.73 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Baseline: Positive Score | 26.8 units on a scale | Standard Deviation 4.16 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Positive Score | -4.5 units on a scale | Standard Deviation 4.68 |
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 | Change at Week 4: Negative Score | -1.5 units on a scale | Standard Deviation 3.78 |
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.314480% CI: [-1.5, 0.68]Mixed Models Analysis
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.5780% CI: [-0.95, 1.25]Mixed Models Analysis
Comparison: Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.003480% CI: [-4.4, -1.59]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.094280% CI: [-1.9, -0.02]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.20380% CI: [-1.56, 0.33]Mixed Models Analysis
Comparison: Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.090780% CI: [-2.48, -0.05]Mixed Models Analysis
Comparison: General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.290480% CI: [-2.45, 0.97]Mixed Models Analysis
Comparison: General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.47180% CI: [-1.82, 1.62]Mixed Models Analysis
Comparison: General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.017280% CI: [-5.86, -1.45]Mixed Models Analysis
Secondary
Clinical Global Impression - Improvement (CGI-I) Score
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed? Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time frame: Week 4
Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-02545920 5 mg | Clinical Global Impression - Improvement (CGI-I) Score | 3.1 units on a scale | Standard Deviation 0.98 |
| PF-02545920 15 mg | Clinical Global Impression - Improvement (CGI-I) Score | 3.3 units on a scale | Standard Deviation 1.35 |
| Risperidone 3 mg | Clinical Global Impression - Improvement (CGI-I) Score | 2.7 units on a scale | Standard Deviation 0.89 |
| Placebo | Clinical Global Impression - Improvement (CGI-I) Score | 3.2 units on a scale | Standard Deviation 1.05 |
Comparison: MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.359880% CI: [-0.32, 0.18]Mixed Models Analysis
Comparison: MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.727580% CI: [-0.13, 0.37]Mixed Models Analysis
Comparison: MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.p-value: 0.001980% CI: [-1.07, -0.42]Mixed Models Analysis
Secondary
Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)
Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.
Time frame: Day 1 up to Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 5 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | WBC | 0 participants |
| PF-02545920 5 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | ANC | 6 participants |
| PF-02545920 15 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | ANC | 6 participants |
| PF-02545920 15 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | WBC | 0 participants |
| Risperidone 3 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | WBC | 0 participants |
| Risperidone 3 mg | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | ANC | 0 participants |
| Placebo | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | WBC | 0 participants |
| Placebo | Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) | ANC | 8 participants |
Secondary
Number of Participants With Clinically Significant Changes in Physical Examinations
Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.
Time frame: Screening, Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 5 mg | Number of Participants With Clinically Significant Changes in Physical Examinations | 0 participants |
| PF-02545920 15 mg | Number of Participants With Clinically Significant Changes in Physical Examinations | 0 participants |
| Risperidone 3 mg | Number of Participants With Clinically Significant Changes in Physical Examinations | 0 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Physical Examinations | 0 participants |
Secondary
Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)
Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction \[QTcB\] interval, and QT corrected using Fridericia's correction \[QTcF\]).
Time frame: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 5 mg | Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) | 0 participants |
| PF-02545920 15 mg | Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) | 0 participants |
| Risperidone 3 mg | Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) | 0 participants |
| Placebo | Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) | 0 participants |
Secondary
Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin
Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein \[HDL\], low-density lipoprotein \[LDL\], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c \[HbA1c\] and Prolactin).
Time frame: Day 1 up to Week 4
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 5 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin | 0 participants |
| PF-02545920 15 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin | 0 participants |
| Risperidone 3 mg | Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin | 0 participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin | 0 participants |
Secondary
Number of Participants With Laboratory Test Abnormalities
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN)
Time frame: Screening up to end of study (7 to 10 days after administration of last dose of study medication)
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-02545920 5 mg | Number of Participants With Laboratory Test Abnormalities | 55 participants |
| PF-02545920 15 mg | Number of Participants With Laboratory Test Abnormalities | 58 participants |
| Risperidone 3 mg | Number of Participants With Laboratory Test Abnormalities | 34 participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | 56 participants |
Secondary
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)
Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.
Time frame: Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 2 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 4 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 4 | 3 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 3 | 1 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 4 | 1 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 4 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 2 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 3 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 4 | 1 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 3 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 3 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 4 | 1 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 2 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 3 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 3 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 7 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 2 | 0 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 2 | 1 participants |
| PF-02545920 5 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 4 | 3 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 7 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 3 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 4 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 3 | 1 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 7 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 4 | 4 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 4 | 4 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 7 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 3 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 3 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 4 | 3 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 7 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 3 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 4 | 2 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 7 | 1 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 7 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 2 | 0 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 2 | 1 participants |
| PF-02545920 15 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 7 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 4 | 1 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 4 | 1 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 4 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 7 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 3 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 4 | 1 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 2 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 7 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 4 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 7 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 4 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 7 | 0 participants |
| Risperidone 3 mg | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 2 | 1 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 3 | 2 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 4 | 3 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 2 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 3 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 4 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 1: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 2 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 3 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 4 | 1 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 2 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 3 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 4 | 1 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 3: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 2 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 3 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 4 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 4: Event code 7 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 2 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 3 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | FU: Event code 4 | 0 participants |
| Placebo | Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Week 2: Event code 7 | 0 participants |
Secondary
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.
Time frame: Week 4
Population: FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-02545920 5 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 53.68 units on a scale | Standard Deviation 24.84 |
| PF-02545920 5 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-Effects | 86.43 units on a scale | Standard Deviation 24.45 |
| PF-02545920 5 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 70.46 units on a scale | Standard Deviation 17.46 |
| PF-02545920 5 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global Satisfaction | 56.84 units on a scale | Standard Deviation 28.3 |
| PF-02545920 15 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-Effects | 79.20 units on a scale | Standard Deviation 28.67 |
| PF-02545920 15 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 68.37 units on a scale | Standard Deviation 18.49 |
| PF-02545920 15 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global Satisfaction | 51.02 units on a scale | Standard Deviation 27.79 |
| PF-02545920 15 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 51.90 units on a scale | Standard Deviation 24.28 |
| Risperidone 3 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 75.69 units on a scale | Standard Deviation 15.44 |
| Risperidone 3 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-Effects | 87.30 units on a scale | Standard Deviation 22.02 |
| Risperidone 3 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global Satisfaction | 66.07 units on a scale | Standard Deviation 23.38 |
| Risperidone 3 mg | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 63.37 units on a scale | Standard Deviation 24.07 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global Satisfaction | 49.48 units on a scale | Standard Deviation 24.69 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-Effects | 87.41 units on a scale | Standard Deviation 24 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 53.70 units on a scale | Standard Deviation 19.68 |
| Placebo | Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 66.83 units on a scale | Standard Deviation 15.12 |