Schizophrenia
Conditions
Brief summary
The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.
Interventions
DRUGPF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
OTHERPlacebo
Placebo, oral capsule, once daily for 21 days
DRUGAripiprazole
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria include: * Have a current diagnosis of schizophrenia. * Increase in symptoms over the past 2-4 weeks. * Willing to remain inpatients for the duration of the trial.
Exclusion criteria
* Subjects with a current DSM-IV axis I diagnosis other than schizophrenia * Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence * Subjects with a history of treatment resistant schizophrenia * Females of childbearing potential
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Days 7, 14, 20, 21, before discharge and Followup |
| PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression) | Screening, Day 1, 3, 7, 14 and 21 |
| PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) | Screening and Days 1, 3, 7, 14 and 21 |
| PANSS positive, negative, and general psychopathology subscales | Screening, Day 1, 3, 7, 14 and 21 |
| 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 |
Countries
India, Russia, Ukraine, United States
Outcome results
None listed