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?


Study Interventions

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

Study Arms

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

Study Status

Unknown status

Start Date: December 2012

Completed Date: December 2013

Phase: N/A

Type: Interventional


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


More information:

Discuss Fluvoxamine