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Keep this study
Lead
New York State Psychiatric Institute
With
National Institute of Mental Health (NIMH)
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DSM-V diagnosis of schizophrenia or schizoaffective disorder
RBANS Total Scale Score \>62
Willing to provide informed consent
Medically stable for study participation
Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
Judged clinically not to be at significant suicide or violence risk
You may not be if
Substance abuse (excluding nicotine) within last 90 days
ECG abnormality that is clinically significant
Current clozapine use
Participation in a study of investigational medication/device within 4 weeks
Pregnancy, lactation, or lack of use of effective birth control
Active tobacco use
Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC \<3500/mm3, absolute neutrophil count \<1500/mm3, ALT or AST values \>1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
Contraindication to MRI scanning, including metal implants or claustrophobia
Medicinal patch, unless removed
Clareo Health | Clinical Trial of AVL-3288 in Schizophrenia Patients