Status:

UNKNOWN

Effect of Fluvoxamine on Cognition, Behavior, Symptoms and mRNA and Protein Expression in Schizophrenia Patients

Lead Sponsor:

Sha'ar Menashe Mental Health Center

Conditions:

SCHIZOPHRENIA 1 (Disorder)

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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 expressio...

Detailed Description

Clinical studies have shown that adding selective serotonin reuptake inhibitor (SSRI) antidepressants to antipsychotics can improve negative symptoms of schizophrenia in patients unresponsive to antip...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2013

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01832285

Start Date

December 1 2012

End Date

December 1 2013

Last Update

April 23 2013

Active Locations (1)

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Shaar Menashe Mental Health Center

Hadera, Ha Sharon, Israel, 38242