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The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00986531
First received: September 29, 2009
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: AZD8529
Drug: Placebo to match AZD8529
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Functional magnetic resonance imaging (fMRI) [ Time Frame: 1 fMRI on Day 4; 1 fMRI on Day 21 ] [ Designated as safety issue: No ]
  • Computerized neurocognitive tests [ Time Frame: 1 on Day -1; 1 on Day 1 and on Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Day-1; Day 4; Day 17; Day 21 ] [ Designated as safety issue: No ]
  • Electroencephalography (EEG) [ Time Frame: Day 4; Day 21 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
80 mg AZD8529
 Drug: AZD8529
2 capsules by mouth for 3 days
Placebo Comparator: 2
Placebo
 Drug: Placebo to match AZD8529
2 capsules by mouth for 3 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986531

Locations
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raquel Gur Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00986531     History of Changes
Other Study ID Numbers: D2285M00016
Study First Received: September 29, 2009
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
schizophrenia
early phase trials

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013