The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

October 31, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo to match AZD8529
2 capsules by mouth for 3 days
Experimental: 1
80 mg AZD8529
Drug: AZD8529
2 capsules by mouth for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional magnetic resonance imaging (fMRI)
Time Frame: 1 fMRI on Day 4; 1 fMRI on Day 21
1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
Time Frame: 1 on Day -1; 1 on Day 1 and on Day 21
1 on Day -1; 1 on Day 1 and on Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Day-1; Day 4; Day 17; Day 21
Day-1; Day 4; Day 17; Day 21
Electroencephalography (EEG)
Time Frame: Day 4; Day 21
Day 4; Day 21
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
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
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
Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Raquel Gur, Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2285M00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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