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OpenTrials
Completed

NCT Number: NCT00567203

A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of schizophrenia
  • In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
  • Stable symptoms of schizophrenia for at least 3 months.

Exclusion criteria

  • Subjects with a psychiatric disorder other than schizophrenia
  • Substance dependence or abuse
  • Women who have child bearing potential.

Treatment and study plan

PF-3463275

Drug

PF-3463275 10mg

Placebo

Drug

Placebo

Primary outcomes

  1. Change from baseline in the CNS Vital Signs Cognition Battery composite score

    Time frame: 6 days

  2. Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.

    Time frame: 38 days

  3. Pharmacokinetics of PF-3463275

    Time frame: 6 days

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: 6 days

  2. Change from baseline in the CNS Vital Signs Cognition Battery domain scores

    Time frame: 6 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 4, 2007
Registry last updated
Oct 2, 2008

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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