Clinical trial NCT00580125: Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-24
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
timeFrame: 5 weeks
measure: Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
timeFrame: 5 weeks
measure: Positive and Negative Symptom Scale (PANSS) total score.
timeFrame: Screening, Day 1, 3, 7, 14 and 21
measure: 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),
timeFrame: 5 weeks
measure: Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
timeFrame: 4 weeks
Secondary outcomes:
measure: PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
timeFrame: Screening, Day 1, 3, 7, 14 and 21
measure: PANSS positive, negative, and general psychopathology subscales
timeFrame: Screening, Day 1, 3, 7, 14 and 21
measure: Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
timeFrame: Screening and Days 1, 3, 7, 14 and 21
measure: NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
timeFrame: Days 1 and 21
measure: Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Day 21
measure: Pharmacokinetics
timeFrame: Days 7, 14, 20, 21, before discharge and Followup
measure: PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
timeFrame: Screening and Days 1, 3, 7, 14 and 21
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bridgeton
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Florissant
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Charles
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Udupi
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
city: Gatchina district
country: Russian Federation
facility: Pfizer Investigational Site
state: Leningrad region
city: Khotkovo
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Simferopol
country: Ukraine
facility: Pfizer Investigational Site
state: Crimea
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kiev
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lugansk
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: