Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Toxoplasmosis, Schizophrenia
About this trial
This is an interventional treatment trial for Toxoplasmosis focused on measuring schizophrenia, toxoplasmosis
Eligibility 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.
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sodium Valproate treatment
Placebo
Sodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment grou, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects.
Placebo Comparator: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects.