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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00580125
First received: December 20, 2007
Last updated: April 16, 2012
Last verified: January 2011
  Purpose

The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.


Condition Intervention Phase
Schizophrenia
Drug: PF-00217830
Other: Placebo
Drug: Aripiprazole
Phase 2

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
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale (PANSS) total score. [ Time Frame: Screening, Day 1, 3, 7, 14 and 21 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression) [ Time Frame: Screening, Day 1, 3, 7, 14 and 21 ] [ Designated as safety issue: No ]
  • PANSS positive, negative, and general psychopathology subscales [ Time Frame: Screening, Day 1, 3, 7, 14 and 21 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement) [ Time Frame: Screening and Days 1, 3, 7, 14 and 21 ] [ Designated as safety issue: No ]
  • NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF. [ Time Frame: Days 1 and 21 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: Days 7, 14, 20, 21, before discharge and Followup ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A2 Drug: PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
Placebo Comparator: A5 Other: Placebo
Placebo, oral capsule, once daily for 21 days
Active Comparator: A4 Drug: Aripiprazole
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Other Name: Abilify
Experimental: A3 Drug: PF-00217830
PF-00217830 15 mg, oral capsule, once daily for 21 days
Experimental: A1 Drug: PF-00217830
PF-00217830 2 mg, oral capsule, once daily for 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580125

Locations
United States, California
Pfizer Investigational Site
Garden Grove, California, United States, 92845
Pfizer Investigational Site
Torrance, California, United States, 90502
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20016
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
Pfizer Investigational Site
Bridgeton, Missouri, United States, 63044-2588
Pfizer Investigational Site
Florissant, Missouri, United States, 63033
Pfizer Investigational Site
St. Charles, Missouri, United States, 63304
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11203
India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site
Mangalore, Karnataka, India, 575001
Pfizer Investigational Site
Udupi, Karnataka, India, 576 102
Pfizer Investigational Site
Pune, Maharashtra, India, 411 004
Pfizer Investigational Site
Pune, India, 411 030
Russian Federation
Pfizer Investigational Site
Gatchina district, Leningrad region, Russian Federation, 188357
Pfizer Investigational Site
Khotkovo, Russian Federation, 141371
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194214
Ukraine
Pfizer Investigational Site
Simferopol, Crimea, Ukraine, 95006
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49115
Pfizer Investigational Site
Donetsk, Ukraine, 83037
Pfizer Investigational Site
Kharkiv, Ukraine, 61018
Pfizer Investigational Site
Kharkiv, Ukraine, 61068
Pfizer Investigational Site
Kiev, Ukraine, 02660
Pfizer Investigational Site
Kyiv, Ukraine, 01030
Pfizer Investigational Site
Lugansk, Ukraine, 91045
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00580125     History of Changes
Other Study ID Numbers: A7251006
Study First Received: December 20, 2007
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014