Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Mansoura University; Stanley Medical Research Institute
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Written informed consent

• Adult men or women (ages 18-50 years)

• Schizophrenia / schizoaffective disorder (DSM IV)

• Duration of illness < 5 years (since onset of psychosis)

• On a stable dose of an antipsychotic for at least a month

• Scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.

Exclusion Criteria:

• Substance abuse in the past month/dependence past 6 months

• History of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy;

• Medical conditions that are judged by the consulting internist and research staff to be unstable

• Pregnant or breast-feeding women

• Known allergy or serious adverse event to DEP, Received Chlorpromazine, Trimethoprim or DEP for up to 6 months prior to study entry.