Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: PF-00217830
* Other: Placebo
* Drug: Aripiprazole
* Drug: PF-00217830
* Drug: PF-00217830


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A2<br> | Drug: PF-00217830<br>* PF-00217830 5 mg, oral capsule, once daily for 21 days<br>|
| Placebo Comparator: A5<br> | Other: Placebo<br>* Placebo, oral capsule, once daily for 21 days<br>|
| Active Comparator: A4<br> | Drug: Aripiprazole<br>* Aripiprazole 15 mg, oral capsule, once daily for 21 days<br>* Other names: Abilify;|
| Experimental: A3<br> | Drug: PF-00217830<br>* PF-00217830 15 mg, oral capsule, once daily for 21 days<br>|
| Experimental: A1<br> | Drug: PF-00217830<br>* PF-00217830 2 mg, oral capsule, once daily for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |