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Completed

NCT Number: NCT00580125

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Bangalore, Karnataka, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-00217830

Drug

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

Placebo

Other

Placebo, oral capsule, once daily for 21 days

Aripiprazole

Drug

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

Other names: Abilify

Primary outcomes

  1. 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

  2. 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

  3. Positive and Negative Symptom Scale (PANSS) total score.

    Time frame: Screening, Day 1, 3, 7, 14 and 21

  4. 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

  5. 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

Secondary outcomes

  1. PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)

    Time frame: Screening, Day 1, 3, 7, 14 and 21

  2. PANSS positive, negative, and general psychopathology subscales

    Time frame: Screening, Day 1, 3, 7, 14 and 21

  3. Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)

    Time frame: Screening and Days 1, 3, 7, 14 and 21

  4. NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.

    Time frame: Days 1 and 21

  5. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: Day 21

  6. Pharmacokinetics

    Time frame: Days 7, 14, 20, 21, before discharge and Followup

  7. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 24, 2007
Registry last updated
Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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