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
|Condition or disease||Intervention/treatment||Phase|
|SCHIZOPHRENIA 1 (Disorder)||Drug: fluvoxamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Tablets of Fluvoxamine in dosage 100mg/day will be added to the treatment regimen and continued for 6 weeks
100mg/day, PO(in the mouth) each day during 6 weeks
Other Name: Favoxile
- 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
- 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.
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
|Contact: Prof.Silver Henry, Professor||046278888||Silver@sm.health.gov.il|
|Contact: Arbitman Marina, Doctorfirstname.lastname@example.org|
|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|
|Principal Investigator:||Silver Henry, Professor||Shaar Menashe Mental Health Center Affilated to Medical Faculty of Technion University|