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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

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Depression, Affective Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Eligibility Criteria

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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