A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia

Schizophrenia Clinical Trial

Official title:

A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00686400
• Other study ID #: 07R-1815, SMRI
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2008
• Last updated: January 22, 2010
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2008
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Silke Bachmann, MD, assistant prof. psychiatry
• Phone: 49-345-557
• Email: silke.bachmann[@]medizin.uni-halle.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Environmental risk factors for the development of schizophrenia include infections during the perinatal period or later in life with Toxoplasma gondii (TG) being one of the candidate agents. A recent review (Torrey and Yolken, 2003) on TG in schizophrenia and other serious mental disorder reported higher antibodies to TG in patients compared to controls in 18 of 19 studies, one having been conducted by the investigators group. In a second, independent study on first-episode schizophrenia (n=56) and control subjects (n=32), sera were sampled and standard instruments used to assess diagnoses and psychopathology, respectively to screening controls.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Other:
• TAU = treatment as usual
medication and psychosocial interventions to be chosen by treating psychiatrist

Locations

Country	Name	City	State
Germany	Dpt. of Psychiatry, University of Frankfurt	Frankfurt/Main
Germany	Dept. of Psychiatry, University of Halle (Saale)	Halle (Saale)
Germany	Dept. of Psychiatry, University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Bachmann S, Schröder 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. Epub 2005 Apr 22. — View Citation

Torrey EF, Yolken RH. Toxoplasma gondii and schizophrenia. Emerg Infect Dis. 2003 Nov;9(11):1375-80. Review. — View Citation

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. Epub 2001 Feb 28. Erratum in: Clin Infect Dis 2001 Apr 15;32(8):1247. Rouslanova I [corrected to Ruslanova I]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	falling levels of Toxoplasma IgG titers parallel clinical improvement over time, 2 follow-ups at 6 and 12 months are planned		3 years	No
Secondary	clinical improvement; outcome: functioning and psychopathology		3 years	No

External Links

•   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