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

NCT ID: NCT00300404

Last Updated: 2006-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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daraprim

Intervention Type DRUG

pyrimethamine

Intervention Type DRUG

folinic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Zentrum für Integrative Psychiatrie

OTHER

Sponsor Role lead

Principal Investigators

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Dunja Hinze-Selch, MD

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Integrative Psychiatrie

Other Identifiers

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SMRI grant # 01T-404

Identifier Type: -

Identifier Source: secondary_id

TOXO-KI-TT

Identifier Type: -

Identifier Source: org_study_id