A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia
NCT ID: NCT00686400
Last Updated: 2010-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
360 participants
OBSERVATIONAL
2008-05-31
2011-05-31
Brief Summary
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For the total sample, contacts with animals during pregnancy and age emerged as a non-significant predictors of TG IgG titers. Means of patients' and controls' TG IgG titers did not differ significantly but variances did; a subgroup of patients' titers reached much higher levels than those of controls. Patients in the high TG IgG subgroup were older (p=0.001), also they were older when psychiatric symptoms appeared, more individuals had regular animal contacts during pregnancy, or rural upbringing including regular animal contact, more consumption of raw meat, and a higher absolute treatment response (all trend levels). Regarding the short term course of patients, the investigators detected decreasing IgG titers in several individuals A power analysis demonstrated that results fell short of significance due to lack of statistical power. Based on the power analysis, the investigators propose an opel label, multicenter study at three regionally different sites within Germany (Halle, Hamm, Heidelberg). The investigators intent to study 173 first-episode patients with schizophrenia, schizoaffective, and schizophreniform disorder and 173 matched controls.
The investigators hypothesize that - according to the heterogeneity of the illness - a subgroup of patients will exhibit higher TG IgG titers compared to the remaining patients and to controls; that this subgroup will have had regular contact with animals during pregnancy and early life as well as developmental delays; and that clinical improvement, response to treatment, and subjective well-being will run parallel with TG IgG decrease.
Patients shall be assessed on admission to hospital, at discharge and at 6- and 12-month-follow-up with respect to TG antibody titers, symptomatology, neuropsychology, predictors of outcome, quality of life, and neurological soft signs. In controls two assessments shall be performed, 12 months apart. All foreseen assessments will be performed using standard measurement instruments with sound reliability and validity such as the SCID and the PANSS. Exposure to cats, other warm-blooded life-stock, and raw meat will be assessed using a special questionnaire.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1: FE
FE = first episode schizophrenia
TAU = treatment as usual
medication and psychosocial interventions to be chosen by treating psychiatrist
2: CO
CO = age and gender-matched control subjects
No interventions assigned to this group
Interventions
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TAU = treatment as usual
medication and psychosocial interventions to be chosen by treating psychiatrist
Eligibility Criteria
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Inclusion Criteria
* Key inclusion criteria will be a first episode of schizophrenia, schizoaffective or schizophreniform disorder.
Exclusion Criteria:
* Exclusion criteria will be major organic and substance induced disorders, refusal or withdrawal of IC.
18 Years
65 Years
ALL
Yes
Sponsors
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Heidelberg University
OTHER
Martin-Luther-Universität Halle-Wittenberg
OTHER
Responsible Party
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Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle
Principal Investigators
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Silke Bachmann, MD, assistant prof. psychiatry
Role: PRINCIPAL_INVESTIGATOR
Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle (Saale), Germany
Locations
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Dpt. of Psychiatry, University of Frankfurt
Frankfurt am Main, , Germany
Dept. of Psychiatry, University of Halle (Saale)
Halle, , Germany
Dept. of Psychiatry, University of Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Johannes Schroeder, MD, professor of psychiatry
Role: CONTACT
Facility Contacts
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References
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Torrey EF, Yolken RH. Toxoplasma gondii and schizophrenia. Emerg Infect Dis. 2003 Nov;9(11):1375-80. doi: 10.3201/eid0911.030143.
Yolken RH, Bachmann S, Ruslanova I, Lillehoj E, Ford G, Torrey EF, Schroeder J. Antibodies to Toxoplasma gondii in individuals with first-episode schizophrenia. Clin Infect Dis. 2001 Mar 1;32(5):842-4. doi: 10.1086/319221. Epub 2001 Feb 28.
Bachmann S, Schroder J, Bottmer C, Torrey EF, Yolken RH. Psychopathology in first-episode schizophrenia and antibodies to Toxoplasma gondii. Psychopathology. 2005 Mar-Apr;38(2):87-90. doi: 10.1159/000085349. Epub 2005 Apr 22.
Related Links
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The SMRI funds this study, sample analyses wil be made at the Stanley Laboratory of Developmental Neurovirology at the Johns Hopkins University, Baltimore, MD, USA
Other Identifiers
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07R-1815, SMRI
Identifier Type: -
Identifier Source: org_study_id
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