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

Sponsor
Zentrum für Integrative Psychiatrie (Other)
Overall Status
Completed
CT.gov ID
NCT00300404
Collaborator
Stanley Medical Research Institute (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2002
Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Psychopathology ratings []

Secondary Outcome Measures

  1. TG infection parameters []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zentrum für Integrative Psychiatrie
  • Stanley Medical Research Institute

Investigators

  • Principal Investigator: Dunja Hinze-Selch, MD, Zentrum für Integrative Psychiatrie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00300404
Other Study ID Numbers:
  • TOXO-KI-TT
  • SMRI grant # 01T-404
First Posted:
Mar 8, 2006
Last Update Posted:
May 22, 2006
Last Verified:
Mar 1, 2006

Study Results

No Results Posted as of May 22, 2006