Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Zentrum für Integrative Psychiatrie
ClinicalTrials.gov Identifier:
NCT00300404
First received: March 7, 2006
Last updated: May 19, 2006
Last verified: March 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

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

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

Keywords provided by Zentrum für Integrative Psychiatrie:
Schizophrenia
Psychosis
Depression
Affective Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Schizophrenia
Toxoplasmosis
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Coccidiosis
Protozoan Infections
Parasitic Diseases
Leucovorin
Folic Acid
Levoleucovorin
 Pyrimethamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013