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

NCT00686400 | Unknown

• 1 other identifier: 07R-1815, SMRI
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

schizophrenia; first-episode; infection; Toxoplasma gondii; levels of IgG antibodies to TG

Outcome Measures

Primary Outcomes (1)

• falling levels of Toxoplasma IgG titers parallel clinical improvement over time, 2 follow-ups at 6 and 12 months are planned

  3 years

Secondary Outcomes (1)

• clinical improvement; outcome: functioning and psychopathology

  3 years

Study Arms (2)

1: FE

FE = first episode schizophrenia

Other: TAU = treatment as usual

2: CO

CO = age and gender-matched control subjects

Interventions

TAU = treatment as usual OTHER

medication and psychosocial interventions to be chosen by treating psychiatrist

1: FE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who are admitted to inpatient treatment due to a first episode of psychotic symptoms, diagnoses of schizophrenia, schizophreniform and schizoaffective disorder age- and gender-matched control subjects

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead
• Heidelberg University: collaborator

Study Sites (3)

Dpt. of Psychiatry, University of Frankfurt

Frankfurt am Main, 60528, Germany

RECRUITING

Dept. of Psychiatry, University of Halle (Saale)

Halle, 06112, Germany

RECRUITING

Dept. of Psychiatry, University of Heidelberg

Heidelberg, 69115, Germany

RECRUITING

Related Publications (3)

• Torrey EF, Yolken RH. Toxoplasma gondii and schizophrenia. Emerg Infect Dis. 2003 Nov;9(11):1375-80. doi: 10.3201/eid0911.030143.

  PMID: 14725265 BACKGROUND

• 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.

  PMID: 11229859 BACKGROUND

• 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.

  PMID: 15855832 BACKGROUND

Related 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

Biospecimen

Retention: SAMPLES WITH DNA

serum, CSF if patients agree to lumbar puncture all frozen and stored at -80 degree Celsius until analysis

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Infections

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Silke Bachmann, MD, assistant prof. psychiatry

  Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle (Saale), Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silke Bachmann, MD, assistant prof. psychiatry

CONTACT

49-345-557; silke.bachmann@medizin.uni-halle.de

Johannes Schroeder, MD, professor of psychiatry

CONTACT

49-6221-56; johannes.schroeder@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 29, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: January 25, 2010

Record last verified: 2008-05

Locations

DE (3)