Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
Primary Purpose
Schizophrenia, Major Depression
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
daraprim
pyrimethamine
folinic acid
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Depression, Affective Disorder
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Psychopathology ratings
Secondary Outcome Measures
TG infection parameters
Full Information
NCT ID
NCT00300404
First Posted
March 7, 2006
Last Updated
May 19, 2006
Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00300404
Brief Title
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
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 Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zentrum für Integrative Psychiatrie
Collaborators
Stanley Medical Research Institute
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Major Depression
Keywords
Schizophrenia, Psychosis, Depression, Affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
daraprim
Intervention Type
Drug
Intervention Name(s)
pyrimethamine
Intervention Type
Drug
Intervention Name(s)
folinic acid
Primary Outcome Measure Information:
Title
Psychopathology ratings
Secondary Outcome Measure Information:
Title
TG infection parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunja Hinze-Selch, MD
Organizational Affiliation
Zentrum für Integrative Psychiatrie
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
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