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

NCT00580125 | Completed Phase 2

• 1 other identifier: A7251006
• Study Type: interventional
• Target: 164
• Locations: 4 countries
• Sites: 26

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (5)

A2

EXPERIMENTAL

Drug: PF-00217830

A5

PLACEBO COMPARATOR

Other: Placebo

A4

ACTIVE COMPARATOR

Drug: Aripiprazole

A3

EXPERIMENTAL

Drug: PF-00217830

A1

EXPERIMENTAL

Drug: PF-00217830

Interventions

PF-00217830 DRUG

PF-00217830 5 mg, oral capsule, once daily for 21 days

A2

Placebo OTHER

Placebo, oral capsule, once daily for 21 days

A5

Aripiprazole DRUG

Aripiprazole 15 mg, oral capsule, once daily for 21 days

Also known as: Abilify

A4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (26)

Pfizer Investigational Site

Garden Grove, California, 92845, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Bridgeton, Missouri, 63044-2588, United States

Location

Pfizer Investigational Site

Florissant, Missouri, 63033, United States

Location

Pfizer Investigational Site

Saint Charles, Missouri, 63304, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11203, United States

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Mangalore, Karnataka, 575001, India

Location

Pfizer Investigational Site

Udupi, Karnataka, 576 102, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 004, India

Location

Pfizer Investigational Site

Pune, 411 030, India

Location

Pfizer Investigational Site

Gatchina District, Leningradskaya Oblast', 188357, Russia

Location

Pfizer Investigational Site

Khot'kovo, 141371, Russia

Location

Pfizer Investigational Site

Moscow, 115522, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 190121, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194214, Russia

Location

Pfizer Investigational Site

Simferopol, Autonomous Republic of Crimea, 95006, Ukraine

Location

Pfizer Investigational Site

Kiev, Ukraine, 02660, Ukraine

Location

Pfizer Investigational Site

Dnipropetrovsk, 49115, Ukraine

Location

Pfizer Investigational Site

Donetsk, 83037, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61018, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61068, Ukraine

Location

Pfizer Investigational Site

Kyiv, 01030, Ukraine

Location

Pfizer Investigational Site

Luhansk, 91045, Ukraine

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia

Interventions

PF 00217830; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 18, 2012

Record last verified: 2011-01

Locations

IN (5); US (8); RU (5); UA (8)