SCHIZOPHRENIA 1 (Disorder) | Effect of Fluvoxamine on Cognition, Behavior, Symptoms and mRNA and Protein Expression in Schizophrenia Patients
SCHIZOPHRENIA 1 (Disorder) research study
What is the primary objective of this study?
The purpose of this study is to determine effect of Fluvoxamine augmentation on cognitive function , aggressive behavior , clinical symptoms and mRNA (messenger ribonucleic acid) and protein expression in human peripheral mononuclear blood cells (PMC) in medicated schizophrenia patients
Who is eligible to participate?
Inclusion Criteria: - Age 18-65 - A diagnosis of schizophrenia (DSM-IVTR) - Antipsychotic dose unchanged for at least 2 weeks prior to study - SANS score>= 3 on at least one of the global measures of affective blunting, alogia or avolition. - Knowledge of Hebrew Exclusion Criteria: - Dementia or other serious neurological disorders - History of alcohol or drug use - Patients with a legal guardian - Patients involuntarily hospitalized by order of the district psychiatrist - Use of antidepressants within 1 month of the study - Renal or hepatic disorder - Patients with upper GI bleeds - Patients with SIADH syndrome - Pregnant woman Criteria for the cessation of the study after initial commencement - Severe adverse events (including but not only GI, cardiovascular, neurologic, hematologic or urologic severe adverse events) - Emergent suicidality - Emergence of hypomanic or manic symptoms - If the subject requests to stop
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
SCHIZOPHRENIA 1 (Disorder)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:fluvoxamine100mg/day, PO(in the mouth) each day during 6 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FluvoxamineTablets of Fluvoxamine in dosage 100mg/day will be added to the treatment regimen and continued for 6 weeks
Start Date: December 2012
Completed Date: December 2013
Primary Outcome: effect of SSRI augmentation on cognitive function in schizophrenia patients
Secondary Outcome: effect of SSRI augmentation on the RNA and protein products in peripheral mononuclear cells
Study sponsors, principal investigator, and references
Principal Investigator: Silver Henry, Professor
Lead Sponsor: Sha’ar Menashe Mental Health Center