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Completed

NCT Number: NCT00986531

The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder

Exclusion criteria

  • ECT in the last 6 months
  • Substance abuse or dependence
  • History of claustrophobia

Treatment and study plan

AZD8529

Drug

2 capsules by mouth for 3 days

Placebo to match AZD8529

Drug

2 capsules by mouth for 3 days

Primary outcomes

  1. Functional magnetic resonance imaging (fMRI)

    Time frame: 1 fMRI on Day 4; 1 fMRI on Day 21

  2. Computerized neurocognitive tests

    Time frame: 1 on Day -1; 1 on Day 1 and on Day 21

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Day-1; Day 4; Day 17; Day 21

  2. Electroencephalography (EEG)

    Time frame: Day 4; Day 21

  3. Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,

    Time frame: Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35

  4. Suicidality assessment, collection of adverse events

    Time frame: Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Nov 1, 2011

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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