The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986531
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: AZD8529 Drug: Placebo to match AZD8529 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : November 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986531

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

Responsible Party: AstraZeneca Identifier: NCT00986531     History of Changes
Other Study ID Numbers: D2285M00016
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by AstraZeneca:
early phase trials

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders