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

Phase 3

Completed

• Conditions: Schizophrenia; Major Depression

• Registration Number: NCT00300404
• Lead Sponsor: Zentrum für Integrative Psychiatrie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study Completion: 2005-09
• Status Verified: 2006-03
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Last Update Submitted: 2006-05-19
• Last Update Posted: 2006-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychopathology ratings

Secondary Outcome Measures

Name	Time	Method
TG infection parameters