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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300404

Enrollment

Registered

2006-03-08

Start date

2002-01-31

Completion date

2005-09-30

Last updated

2006-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression, Schizophrenia

Keywords

Schizophrenia, Psychosis, Depression, Affective Disorder

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.

Interventions

DRUGdaraprim

DRUGpyrimethamine

DRUGfolinic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Psychopathology ratings	—

Secondary

Measure	Time frame
TG infection parameters	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026