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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300404
• Other study ID #: TOXO-KI-TT
• Secondary ID: SMRI grant # 01T
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: May 19, 2006
• Start date: January 2002
• Est. completion date: September 2005

Study information

• Verified date: March 2006
• Source: Zentrum für Integrative Psychiatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Schizophrenia

Intervention

Drug:
• daraprim

• pyrimethamine

• folinic acid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zentrum für Integrative Psychiatrie	Stanley Medical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychopathology ratings
Secondary	TG infection parameters