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Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
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).
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Mansoura University Hospital
Al Mansurah, Egypt
Start Date
April 1, 2013
Primary Completion Date
October 30, 2017
Completion Date
December 31, 2017
Last Updated
February 14, 2018
109
ACTUAL participants
Sodium Valproate treatment
DRUG
Placebo
DRUG
Lead Sponsor
University of Pittsburgh
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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