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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00580125
• Date of registration: 20/12/2007
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
• Scientific title: 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
• Date of first enrolment: November 2007
• Target sample size: 164
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00580125
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

India, Russian Federation, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: PF-00217830

Other: Placebo

Drug: Aripiprazole

Primary Outcome(s)

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]

Positive and Negative Symptom Scale (PANSS) total score. [Time Frame: Screening, Day 1, 3, 7, 14 and 21]

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]

Secondary Outcome(s)

NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF. [Time Frame: Days 1 and 21]

Treatment Satisfaction Questionnaire for Medication (TSQM) [Time Frame: Day 21]

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]

Pharmacokinetics [Time Frame: Days 7, 14, 20, 21, before discharge and Followup]

Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement) [Time Frame: Screening and Days 1, 3, 7, 14 and 21]

PANSS positive, negative, and general psychopathology subscales [Time Frame: Screening, Day 1, 3, 7, 14 and 21]

PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression) [Time Frame: Screening, Day 1, 3, 7, 14 and 21]

Secondary ID(s)

A7251006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors