NCT01832285

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 23, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

February 14, 2013

Last Update Submit

April 22, 2013

Conditions

SCHIZOPHRENIA 1 (Disorder)

Keywords

fluvoxaminecognitionschizophreniaprotein expression

Outcome Measures

Primary Outcomes (1)

  • effect of SSRI augmentation on cognitive function in schizophrenia patients

    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

    1 year

Secondary Outcomes (1)

  • effect of SSRI augmentation on the RNA and protein products in peripheral mononuclear cells

    1 year

Study Arms (1)

Fluvoxamine

EXPERIMENTAL

Tablets of Fluvoxamine in dosage 100mg/day will be added to the treatment regimen and continued for 6 weeks

Drug: fluvoxamine

Interventions

fluvoxamineDRUG

100mg/day, PO(in the mouth) each day during 6 weeks

Also known as: Favoxile
Fluvoxamine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaar Menashe Mental Health Center

Hadera, Ha Sharon, 38242, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OximesHydroxylaminesAminesOrganic Chemicals

Study Officials

  • Silver Henry, Professor

    Shaar Menashe Mental Health Center Affilated to Medical Faculty of Technion University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof.Silver Henry, Professor

CONTACT

046278888Silver@sm.health.gov.il

Arbitman Marina, Doctor

CONTACT

046278785arbitman@sm.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

April 16, 2013

Study Start

December 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-01

Locations

IL(1)