The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

AstraZeneca59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

AZD8529DRUG

2 capsules by mouth for 3 days

Placebo to match AZD8529DRUG

2 capsules by mouth for 3 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Functional magnetic resonance imaging (fMRI)

Time frame: 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

Secondary Outcomes

Positive and Negative Syndrome Scale (PANSS)

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

Electroencephalography (EEG)

Time frame: 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

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

Data from ClinicalTrials.gov

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