A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder |
Other: TAU = treatment as usual |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia |
- falling levels of Toxoplasma IgG titers parallel clinical improvement over time, 2 follow-ups at 6 and 12 months are planned [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- clinical improvement; outcome: functioning and psychopathology [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, CSF if patients agree to lumbar puncture all frozen and stored at -80 degree Celsius until analysis
| Estimated Enrollment: | 360 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1: FE
FE = first episode schizophrenia
|
Other: TAU = treatment as usual
medication and psychosocial interventions to be chosen by treating psychiatrist
|
|
2: CO
CO = age and gender-matched control subjects
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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.
Contacts and Locations| Contact: Silke Bachmann, MD, assistant prof. psychiatry | 49-345-557 ext 3624 | silke.bachmann@medizin.uni-halle.de |
| Contact: Johannes Schroeder, MD, professor of psychiatry | 49-6221-56 ext 4403 | johannes.schroeder@med.uni-heidelberg.de |
| Germany | |
| Dpt. of Psychiatry, University of Frankfurt | Recruiting |
| Frankfurt/Main, Germany, 60528 | |
| Contact: Johannes Pantel, Professor +49-69-6301 ext 7094 johannes.pantel@kgu.de | |
| Contact: Daniela Hainz, MA +49-69-6301 ext 7094 daniela.hainz@kgu.de | |
| Principal Investigator: Johannes Pantel, Professor | |
| Sub-Investigator: Daniela Hainz, MA | |
| Dept. of Psychiatry, University of Halle (Saale) | Recruiting |
| Halle (Saale), Germany, 06112 | |
| Contact: Silke Bachmann, Deputy Director +49-345-557 ext 3624 silke.bachmann@medizin.uni-halle.de | |
| Sub-Investigator: Michaela Beck, MA | |
| Sub-Investigator: Friederike Haupt, PhD | |
| Dept. of Psychiatry, University of Heidelberg | Recruiting |
| Heidelberg, Germany, 69115 | |
| Contact: Johannes Schroeder, Professor +49-6221-56 ext 4403 johannes.schroeder@med.uni-heidelberg.de | |
| Contact: Kira Krapf, MA +49-6221-56 ext 4403 kira.krapf@med.uni-heidelberg.de | |
| Principal Investigator: Johannes Schroeder, Professor | |
| Principal Investigator: Kira Krapf, MA | |
| Principal Investigator: | Silke Bachmann, MD, assistant prof. psychiatry | Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle (Saale), Germany |
More Information
Additional Information:
Publications:
| Responsible Party: | Silke Bachmann, MD, Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle |
| ClinicalTrials.gov Identifier: | NCT00686400 History of Changes |
| Other Study ID Numbers: | 07R-1815, SMRI |
| Study First Received: | May 27, 2008 |
| Last Updated: | January 22, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
|
schizophrenia first-episode infection Toxoplasma gondii levels of IgG antibodies to TG |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013