Genetic Expression in Schizophrenics Treated With SSRI Augmentation: Relationship to Clinical and Cognitive Function

• Status: Unknown status
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In our study we aim to examine the effect of SSRI augmentation on negative symptoms and cognitive function in schizophrenia patients as well as to examine the effect of SSRI augmentation on the RNA and protein products in peripheral mononuclear cells (PMC). Finally, we aim to relate changes in PMC elements to changes in clinical symptoms and cognitive function. Our study hypotheses are that SSRI augmentation of anti-psychotic treatment in schizophrenia patients will improve negative symptoms as well as cognitive symptoms and that this improvement will be related to biochemical changes identifiable in PMC elements.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sha'ar Menashe Mental Health Center; Sha’ar Menashe Mental Health Center
• Treatments: Fluvoxamine

Criteria

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