Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Toxoplasmosis; Schizophrenia
Intervention: Sodium Valproate treatment (Drug); Placebo (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Hader Mansour, MD, Principal Investigator, Affiliation: University of Pittsburgh
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 Details
Official title: Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical SeverityCognitive Domains assessed via the Arabic version of the Penn CNB Social Function assessed via the Quality of Life Scale Cognitive domains assessed via Trails Making Test Social Function -assessed via the GAF scale Social Functioning assessed via the Short Form
Secondary outcome: Side effects
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
Mansoura University Hospital, Mansoura, Egypt
Additional Information
Starting date: March 2013
Last updated: May 26, 2015
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