NCT00645580

Brief 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.

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
15

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable schizophrenia

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

First Submitted

Initial submission to the registry

March 23, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 19, 2009

Status Verified

March 1, 2008

Enrollment Period

1 year

First QC Date

March 23, 2008

Last Update Submit

February 18, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Schedule for the Assessment of Negative Symptoms (SANS)

    0 weeks, 3 weeks, 6 weeks

Secondary Outcomes (10)

  • Schedule for the Assessment of Positive Symptoms (SAPS)

    0 weeks, 3 weeks, 6 weeks

  • Simpson Angus Scale for Extrapyramidal Side Effects (SA)

    0 weeks, 3 weeks, 6 weeks

  • Abnormal Involuntary Movement Scales (AIMS)

    0 weeks, 3 weeks, 6 weeks

  • Calgary Depression Scale

    0 weeks, 3 weeks, 6 weeks

  • Mini Mental State Examination

    0 weeks, 3 weeks, 6 weeks

  • +5 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Drug: Fluvoxamine

Interventions

FluvoxamineDRUG

Fluvoxamine 100mg/day PO for 6 weeks.

Also known as: Favoxil, Luvox, Dumyrox, Fevarin, Faverin
A

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)

Sha'ar Menashe Mental Health Center

Mobile Post Hefer, 37806, Israel

Location

Related Publications (32)

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    PMID: 15967061BACKGROUND

  • Chertkow Y, Weinreb O, Youdim MB, Silver H. Dopamine and serotonin metabolism in response to chronic administration of fluvoxamine and haloperidol combined treatment. J Neural Transm (Vienna). 2007;114(11):1443-54. doi: 10.1007/s00702-007-0753-1. Epub 2007 Jun 18.

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  • Chertkow Y, Weinreb O, Youdim MB, Silver H. Gene expression changes in peripheral mononuclear cells from schizophrenic patients treated with a combination of antipsychotic with fluvoxamine. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1356-62. doi: 10.1016/j.pnpbp.2007.04.016. Epub 2007 Apr 29.

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    PMID: 9915501BACKGROUND

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    PMID: 9381177BACKGROUND

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    PMID: 10560024BACKGROUND

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

  • Goff DC, Midha KK, Sarid-Segal O, Hubbard JW, Amico E. A placebo-controlled trial of fluoxetine added to neuroleptic in patients with schizophrenia. Psychopharmacology (Berl). 1995 Feb;117(4):417-23. doi: 10.1007/BF02246213.

    PMID: 7604142BACKGROUND

  • Guy W (ed). National Institute of Mental Health. Abnormal Involuntary Movement Scale (AIMS). Early Clinical Drug Evaluation Unit Assessment Manual. Rockville, Maryland: US Department of Health and Human Services, 1976; pp. 534-537

    BACKGROUND

  • Ilani T, Ben-Shachar D, Strous RD, Mazor M, Sheinkman A, Kotler M, Fuchs S. A peripheral marker for schizophrenia: Increased levels of D3 dopamine receptor mRNA in blood lymphocytes. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):625-8. doi: 10.1073/pnas.98.2.625. Epub 2001 Jan 9.

    PMID: 11149951BACKGROUND

  • Keefe RS, Lees-Roitman SE, Dupre RL. Performance of patients with schizophrenia on a pen and paper visuospatial working memory task with short delay. Schizophr Res. 1997 Jul 25;26(1):9-14. doi: 10.1016/S0920-9964(97)00037-6.

    PMID: 9376341BACKGROUND

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    PMID: 10784457BACKGROUND

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    PMID: 8381906BACKGROUND

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    PMID: 1333286BACKGROUND

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    BACKGROUND

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    BACKGROUND

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    PMID: 11782102BACKGROUND

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    PMID: 7868850BACKGROUND

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    PMID: 7517496BACKGROUND

  • Wechsler D. Wechsler Adult Intelligence Scale Manual. New York, New York: Guilford Press, 1998; pp. 95-188

    BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OximesHydroxylaminesAminesOrganic Chemicals

Study Officials

  • Henry Silver, PhD

    Sha'ar Menshae Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2008

First Posted

March 27, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 19, 2009

Record last verified: 2008-03

Locations

IL(1)