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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heidelberg University
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00686400
First received: May 27, 2008
Last updated: January 22, 2010
Last verified: May 2008
  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

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686400

Contacts
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

Locations
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         
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Heidelberg University
Investigators
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 August 01, 2014