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Clinical Trial Summary

This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes, as well as changes in overall social function. We will also explore the relative efficacy of Sodium Valproate (Depakote, DEP) in improving clinical and overall social function among TOX exposed and unexposed patients.

Hypotheses

1. At baseline, TOX exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with SZ.

2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in SZ, particularly among TOX exposed SZ patients.

3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP and TH levels).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02011750
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 4
Start date April 1, 2013
Completion date December 31, 2017

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