The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
PF-00217830 5 mg, oral capsule, once daily for 21 days
Placebo, oral capsule, once daily for 21 days
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Pfizer Investigational Site
Garden Grove, California, United States
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Time frame: 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).
Time frame: 5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Time frame: 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),
Time frame: 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).
Time frame: 4 weeks
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Time frame: Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Time frame: Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Time frame: 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.
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PF-00217830 15 mg, oral capsule, once daily for 21 days
PF-00217830 2 mg, oral capsule, once daily for 21 days
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Bridgeton, Missouri, United States
Pfizer Investigational Site
Florissant, Missouri, United States
Pfizer Investigational Site
Saint Charles, Missouri, United States
Pfizer Investigational Site
Brooklyn, New York, United States
Pfizer Investigational Site
Bangalore, Karnataka, India
Pfizer Investigational Site
Mangalore, Karnataka, India
...and 16 more locations
Time frame: Days 1 and 21
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Day 21
Pharmacokinetics
Time frame: Days 7, 14, 20, 21, before discharge and Followup
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
Time frame: Screening and Days 1, 3, 7, 14 and 21