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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole; Other: Placebo; Drug: PF-00217830

• Registration Number: NCT00580125
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-24
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-09-09
• Disposition First Submitted QC: 2009-09-09
• Disposition First Posted: 2009-09-11
• Status Verified: 2011-01
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A4	Aripiprazole	-
A5	Placebo	-
A3	PF-00217830	-
A1	PF-00217830	-
A2	PF-00217830	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇦 Lugansk, Ukraine