Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT00300404
First received: March 7, 2006
Last updated: May 19, 2006
Last verified: March 2006

March 7, 2006
May 19, 2006
January 2002
Not Provided
Psychopathology ratings
Same as current
Complete list of historical versions of study NCT00300404 on ClinicalTrials.gov Archive Site
TG infection parameters
Same as current
Not Provided
Not Provided
 
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study

We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Schizophrenia
  • Major Depression
  • Drug: daraprim
  • Drug: pyrimethamine
  • Drug: folinic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2005
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Inclusion Criteria:

  • Schizophrenia or Major Depression
  • Both genders
  • Adult
  • Patients are able to give informed consent

Exclusion Criteria:

  • Additional diagnosis of substance abuse/dependency
  • Continuous treatment with medication not compatible with study medication
  • Medical status not compatible with study medication
  • Any condition that increases study risk considerably
  • Pregnancy, nursing
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00300404
TOXO-KI-TT, SMRI grant # 01T-404
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Not Provided
Zentrum für Integrative Psychiatrie
Stanley Medical Research Institute
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie
Zentrum für Integrative Psychiatrie
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP