SchizophreniaNCT00686400
A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia
An observational study of Schizophrenia and Schizophreniform Disorder, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- TAU = treatment as usual
- How many people
- 360 participants
- Where
- 3 sitesGermany
- Study dates
- May 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Key inclusion criteria will be a first episode of schizophrenia, schizoaffective or schizophreniform disorder.
Who cannot join
- Exclusion criteria will be major organic and substance induced disorders, refusal or withdrawal of IC.
Trial locations and contacts
3 sites in 1 country.
Silke Bachmann, MD, assistant prof. psychiatry contact
Johannes Schroeder, MD, professor of psychiatry contact
Germany3 sites, 3 recruiting
- Recruiting
Dpt. of Psychiatry, University of Frankfurt
Frankfurt am Main, 60528
Johannes Pantel, Professor, +49-69-6301 ext. 7094, johannes.pantel@kgu.de
Daniela Hainz, MA, +49-69-6301 ext. 7094, daniela.hainz@kgu.de
- Recruiting
Dept. of Psychiatry, University of Halle (Saale)
Halle, 06112
Silke Bachmann, Deputy Director, +49-345-557 ext. 3624, silke.bachmann@medizin.uni-halle.de
Michaela Beck, MA
- Recruiting
Dept. of Psychiatry, University of Heidelberg
Heidelberg, 69115
Johannes Schroeder, Professor, +49-6221-56 ext. 4403, johannes.schroeder@med.uni-heidelberg.de
Kira Krapf, MA, +49-6221-56 ext. 4403, kira.krapf@med.uni-heidelberg.de
About this study
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.
Read more
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.
- Being tested
- TAU = treatment as usual
- Keywords
- schizophrenia, first-episode, infection, Toxoplasma gondii, levels of IgG antibodies to TG
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU = treatment as usualOther
medication and psychosocial interventions to be chosen by treating psychiatrist
| Study group | Role | What they receive |
|---|---|---|
| 1: FE | FE = first episode schizophrenia Receives: Other: TAU = treatment as usual | |
| 2: CO | CO = age and gender-matched control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
falling levels of Toxoplasma IgG titers parallel clinical improvement over time, 2 follow-ups at 6 and 12 months are planned
Measured: 3 years
Secondary outcomes (1)
clinical improvement; outcome: functioning and psychopathology
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Investigators
- Silke Bachmann, MD, assistant prof. psychiatry, Principal investigator, Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle (Saale), Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686400
- Sponsor's protocol ID
- 07R-1815, SMRI
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Torrey EF, Yolken RH. Toxoplasma gondii and schizophrenia. Emerg Infect Dis. 2003 Nov;9(11):1375-80. doi: 10.3201/eid0911.030143.
PubMed 14725265Yolken 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.
PubMed 11229859Bachmann 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.
PubMed 15855832
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00686400
- Acronym / sponsor ID
- 07R-1815, SMRI
- Keywords
- schizophrenia, first-episode, infection, Toxoplasma gondii, levels of IgG antibodies to TG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- May 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: FE | – | Other: TAU = treatment as usualFE = first episode schizophrenia |
| 2: CO | – | –CO = age and gender-matched control subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Key inclusion criteria will be a first episode of schizophrenia, schizoaffective or schizophreniform disorder.
Key exclusion criteria (1 listed)
- Exclusion criteria will be major organic and substance induced disorders, refusal or withdrawal of IC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU = treatment as usualmedication and psychosocial interventions to be chosen by treating psychiatrist | Other | 1: FE |
Primary outcome
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
1 secondary outcome
clinical improvement; outcome: functioning and psychopathology
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
- Background: PubMed 14725265Torrey EF, Yolken RH. Toxoplasma gondii and schizophrenia. Emerg Infect Dis. 2003 Nov;9(11):1375-80. doi: 10.3201/eid0911.030143.
- Background: PubMed 11229859Yolken 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.
- Background: PubMed 15855832Bachmann 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.
- The SMRI funds this study, sample analyses wil be made at the Stanley Laboratory of Developmental Neurovirology at the Johns Hopkins University, Baltimore, MD, USALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silke Bachmann, MD, assistant prof. psychiatry contact
Johannes Schroeder, MD, professor of psychiatry contact
Silke Bachmann, MD, assistant prof. psychiatry principal investigator
Dept. of Psychiatry, Psychotherapy and Psychosomatics, University of Halle (Saale), Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizophreniform Disorder, run by Martin-Luther-Universität Halle-Wittenberg at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Bachmann, MD, assistant prof. psychiatry (49-345-557 ext. 3624, silke.bachmann@medizin.uni-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686400, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2010.