Schizophrenia
Conditions
Keywords
schizophrenia, early phase trials
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.
Interventions
DRUGAZD8529
2 capsules by mouth for 3 days
2 capsules by mouth for 3 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional magnetic resonance imaging (fMRI) | 1 fMRI on Day 4; 1 fMRI on Day 21 |
| Computerized neurocognitive tests | 1 on Day -1; 1 on Day 1 and on Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Day-1; Day 4; Day 17; Day 21 |
| Electroencephalography (EEG) | Day 4; Day 21 |
| Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, | 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 | Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35 |
Countries
United States
Outcome results
None listed