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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300404
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : May 22, 2006
Stanley Medical Research Institute
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Major Depression Drug: daraprim Drug: pyrimethamine Drug: folinic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2002
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. Psychopathology ratings

Secondary Outcome Measures :
  1. TG infection parameters

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300404

Sponsors and Collaborators
Zentrum für Integrative Psychiatrie
Stanley Medical Research Institute
Principal Investigator: Dunja Hinze-Selch, MD Zentrum für Integrative Psychiatrie Identifier: NCT00300404     History of Changes
Other Study ID Numbers: TOXO-KI-TT
SMRI grant # 01T-404
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: May 22, 2006
Last Verified: March 2006

Keywords provided by Zentrum für Integrative Psychiatrie:
Affective Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Folic Acid
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action