Phase 2
N=259
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01175135 ↗Enrolled (actual)
259
Serious AEs
4.7%
Results posted
Mar 2018
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 — 98.1; 97.7; 97.4; 97.2 units on a scale — p=0.2053
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-02545920 (Drug); Placebo (Drug); Risperidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 |
98.1; 97.7; 97.4; 97.2; -15.3; -13.8 | 0.2053 |
| PRIMARY Proportion of Participants With Dystonia Adverse Events |
0.01; 0.08; 0.00; 0.04 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 |
26.9; 26.1; 26.6; 26.8; 23.4; 23.4 | 0.3144 |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 |
5.0; 5.0; 4.9; 5.0; -0.7; -0.7 | 0.1970 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 |
30.9; 30.6; 30.3; 31.0; 23.0; 23.3 | 0.1999 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 |
17.4; 17.3; 17.2; 17.3; -3.7; -3.4 | 0.2727 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Score |
3.1; 3.3; 2.7; 3.2 | 0.3598 |
| SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 |
38.4; 38.5; 38.7; 38.2; 6.3; 6.9 | 0.5429 |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Score |
53.68; 51.90; 63.37; 53.70; 86.43; 79.20 | — |
| SECONDARY Change From Baseline in Body Weight at Week 4 |
86.1; 87.5; 83.9; 84.3; 0.18; -1.23 | — |
| SECONDARY Change From Baseline in Abdominal Girth at Week 4 |
96.5; 97.2; 95.6; 93.5; 0.71; 0.70 | — |
| SECONDARY Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Physical Examinations |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
55; 58; 34; 56 | — |
| SECONDARY Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) |
0; 0; 0; 0; 6; 6 | — |
| 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 |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 |
0.257; 0.500; 0.194; 0.473; 0.095; 0.000 | — |
| SECONDARY Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4 |
0.0019; 0.0163; 0.0000; 0.0126 | — |
| SECONDARY Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) |
1; 1; 0; 1; 1; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01175135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.