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

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ClinicalTrials.gov Identifier: NCT01832285
Recruitment Status : Unknown
Verified January 2013 by Sha'ar Menashe Mental Health Center.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Sha'ar Menashe Mental Health Center

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 expression in human peripheral mononuclear blood cells (PMC) in medicated schizophrenia patients

Condition or disease Intervention/treatment Phase
SCHIZOPHRENIA 1 (Disorder) Drug: fluvoxamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fluvoxamine Augmentation on Cognitive Function , Aggressive Behavior , Clinical Symptoms and mRNA and Protein Expression in Human Peripheral Mononuclear Blood Cells (PMC) in Medicated Schizophrenia Patients
Study Start Date : December 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Fluvoxamine
Tablets of Fluvoxamine in dosage 100mg/day will be added to the treatment regimen and continued for 6 weeks
Drug: fluvoxamine
100mg/day, PO(in the mouth) each day during 6 weeks
Other Name: Favoxile




Primary Outcome Measures :
  1. effect of SSRI augmentation on cognitive function in schizophrenia patients [ Time Frame: 1 year ]

    Clinical state and cognitive function will be assessed prior to fluvoxamine treatment and then during the study period according to the flow sheet below.

    Clinical assessment scales will include:Schedule for the Assessment of Negative Symptoms (SANS),Schedule for the Assessment of Positive Symptoms (SAPS) Simpson Angus Scale for Extrapyramidal Side Effects (SA); Abnormal Involuntary Movement Scales (AIMS); Calgary Depression Scale ,Cognitive assessment will include:Mini Mental State Examination, Dot test , Modified , Digit Span, Finger Tap Test, modified, Wechsler memory tests, Computerized Cognitive Neuropsychological Battery:Computerized judgment of line orientation (CJOLO); Penn face memory test (PFMT); Visual object learning test (VOLT); Abstraction inhibition and working memory task (AIM), Identification of facial emotions (PEAT); Differentiation of facial emotion (EMDIF).

    Behavioral and function assessment , Overt aggression Scale, GAF (DSM IV TR) Critical Events



Secondary Outcome Measures :
  1. effect of SSRI augmentation on the RNA and protein products in peripheral mononuclear cells [ Time Frame: 1 year ]

    Approx 50cc of blood will be taken at baseline,and 1,3 and 6 weeks after the start of fluvoxamine treatment.

    Blood will be collected into heparinized tubes, kept on ice and transported to the laboratory. Blood samples will be processed to enable assay of PMC elements of interest, including chemokine receptors, G protein receptors such as the GABAA receptor , their regulators such as, PKC GSK3 RGS7 and neurotrophins such as BDNF.

    Some of the serum will be frozen for subsequent analyses of antipsychotic drug and neurohormone concentration. The blood samples will be stored in the molecular neuropsychiatry laboratory at the Technion Institute of Technology (Haifa) under the supervision of the principal investigator, Prof. Henry Silver. The samples will be unnamed and numbered. They will be kept for a maximum of 10 years. The participants will be given the option to ask for the destruction of the samples at any time.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832285


Contacts
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Contact: Prof.Silver Henry, Professor 046278888 Silver@sm.health.gov.il
Contact: Arbitman Marina, Doctor 046278785 arbitman@sm.health.gov.il

Locations
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Israel
Shaar Menashe Mental Health Center Recruiting
Hadera, Ha Sharon, Israel, 38242
Contact: Prof. Silver Henry, Professor    046278888    Silver@sm.health.gov.il   
Principal Investigator: Silver Henry, Professor         
Sponsors and Collaborators
Sha'ar Menashe Mental Health Center
Investigators
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Principal Investigator: Silver Henry, Professor Shaar Menashe Mental Health Center Affilated to Medical Faculty of Technion University
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Responsible Party: Sha'ar Menashe Mental Health Center
ClinicalTrials.gov Identifier: NCT01832285    
Other Study ID Numbers: 20120241
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: January 2013
Keywords provided by Sha'ar Menashe Mental Health Center:
fluvoxamine
cognition
schizophrenia
protein expression
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Fluvoxamine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors