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The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A2 | Experimental |
| |
| A5 | Placebo Comparator |
| |
| A4 | Active Comparator |
| |
| A3 | Experimental |
| |
| A1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00217830 | Drug | PF-00217830 5 mg, oral capsule, once daily for 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21). | 5 weeks | |
| Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup). | 5 weeks | |
| Positive and Negative Symptom Scale (PANSS) total score. | Screening, Day 1, 3, 7, 14 and 21 | |
| Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup), | 5 weeks | |
| Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression) | Screening, Day 1, 3, 7, 14 and 21 | |
| PANSS positive, negative, and general psychopathology subscales | Screening, Day 1, 3, 7, 14 and 21 |
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Inclusion Criteria:
Key inclusion criteria include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Garden Grove | California | 92845 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Other |
Placebo, oral capsule, once daily for 21 days |
|
| Aripiprazole | Drug | Aripiprazole 15 mg, oral capsule, once daily for 21 days |
|
|
| PF-00217830 | Drug | PF-00217830 15 mg, oral capsule, once daily for 21 days |
|
| PF-00217830 | Drug | PF-00217830 2 mg, oral capsule, once daily for 21 days |
|
| Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement) | Screening and Days 1, 3, 7, 14 and 21 |
| NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF. | Days 1 and 21 |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | Day 21 |
| Pharmacokinetics | Days 7, 14, 20, 21, before discharge and Followup |
| PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) | Screening and Days 1, 3, 7, 14 and 21 |
| Torrance |
| California |
| 90502 |
| United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Pfizer Investigational Site | Bridgeton | Missouri | 63044-2588 | United States |
| Pfizer Investigational Site | Florissant | Missouri | 63033 | United States |
| Pfizer Investigational Site | Saint Charles | Missouri | 63304 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11203 | United States |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Mangalore | Karnataka | 575001 | India |
| Pfizer Investigational Site | Udupi | Karnataka | 576 102 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 004 | India |
| Pfizer Investigational Site | Pune | 411 030 | India |
| Pfizer Investigational Site | Gatchina District | Leningradskaya Oblast' | 188357 | Russia |
| Pfizer Investigational Site | Khot'kovo | 141371 | Russia |
| Pfizer Investigational Site | Moscow | 115522 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 190121 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194214 | Russia |
| Pfizer Investigational Site | Simferopol | Autonomous Republic of Crimea | 95006 | Ukraine |
| Pfizer Investigational Site | Kiev | Ukraine | 02660 | Ukraine |
| Pfizer Investigational Site | Dnipropetrovsk | 49115 | Ukraine |
| Pfizer Investigational Site | Donetsk | 83037 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61018 | Ukraine |
| Pfizer Investigational Site | Kharkiv | 61068 | Ukraine |
| Pfizer Investigational Site | Kyiv | 01030 | Ukraine |
| Pfizer Investigational Site | Luhansk | 91045 | Ukraine |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C560205 | PF 00217830 |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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