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

This study has been completed.

First Received: March 7, 2006 Last Updated: May 19, 2006 History of Changes

Sponsors and Collaborators:	Zentrum für Integrative Psychiatrie Stanley Medical Research Institute
Information provided by:	Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:	NCT00300404

Purpose

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	Intervention	Phase
Schizophrenia Major Depression	Drug: daraprim Drug: pyrimethamine Drug: folinic acid	Phase III

MedlinePlus related topics: Depression Psychotic Disorders Schizophrenia Toxoplasmosis

Drug Information available for: Leucovorin Pyrimethamine Folic acid Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Zentrum für Integrative Psychiatrie:

Primary Outcome Measures:

Psychopathology ratings

Secondary Outcome Measures:

TG infection parameters

Estimated Enrollment:	40
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300404

Sponsors and Collaborators

Zentrum für Integrative Psychiatrie

Stanley Medical Research Institute

Investigators

Principal Investigator:

Dunja Hinze-Selch, MD

Zentrum für Integrative Psychiatrie

More Information

No publications provided

Study ID Numbers:	TOXO-KI-TT, SMRI grant # 01T-404
Study First Received:	March 7, 2006
Last Updated:	May 19, 2006
ClinicalTrials.gov Identifier:	NCT00300404 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Zentrum für Integrative Psychiatrie:

Schizophrenia
Psychosis
Depression
Affective Disorder

Study placed in the following topic categories:

Pyrimethamine
Protozoan Infections
Vitamin B Complex
Depression
Leucovorin
Trace Elements
Depressive Disorder, Major
Folic Acid Antagonists
Depressive Disorder
Toxoplasmosis
Behavioral Symptoms

Folic Acid
Schizophrenia
Antimalarials
Mental Disorders
Vitamins
Mood Disorders
Psychotic Disorders
Parasitic Diseases
Micronutrients
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pyrimethamine
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Leucovorin
Depressive Disorder, Major
Schizophrenia
Antimalarials
Antiparasitic Agents
Mental Disorders
Vitamins
Therapeutic Uses
Parasitic Diseases

Micronutrients
Schizophrenia and Disorders with Psychotic Features
Protozoan Infections
Depression
Vitamin B Complex
Coccidiosis
Growth Substances
Enzyme Inhibitors
Folic Acid Antagonists
Depressive Disorder
Toxoplasmosis
Pharmacologic Actions
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 07, 2009