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OpenTrials
Completed

NCT Number: NCT00300404

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

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.

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Key information

Conditions

Schizophrenia Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daraprim

Drug

Pyrimethamine

Drug

Folinic acid

Drug

Primary outcomes

  1. Psychopathology ratings

Secondary outcomes

  1. TG infection parameters

Sponsors and collaborators

Lead sponsor

Zentrum für Integrative Psychiatrie

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Mar 8, 2006
Registry last updated
May 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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