NCT00300404

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_3 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
Last Updated

May 22, 2006

Status Verified

March 1, 2006

First QC Date

March 7, 2006

Last Update Submit

May 19, 2006

Conditions

SchizophreniaMajor Depression

Keywords

SchizophreniaPsychosisDepressionAffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Psychopathology ratings

Secondary Outcomes (1)

  • TG infection parameters

Interventions

daraprimDRUG
pyrimethamineDRUG
folinic acidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia or Major Depression
  • Both genders
  • Adult
  • Patients are able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaDepressive Disorder, MajorPsychotic DisordersDepressionMood Disorders

Interventions

PyrimethamineLeucovorin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Dunja Hinze-Selch, MD

    Zentrum für Integrative Psychiatrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 8, 2006

Study Start

January 1, 2002

Study Completion

September 1, 2005

Last Updated

May 22, 2006

Record last verified: 2006-03