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

PHASE4CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

April 1, 2013

Primary Completion Date

October 30, 2017

Study Completion Date

December 31, 2017

Conditions
ToxoplasmosisSchizophrenia
Interventions
DRUG

Sodium Valproate treatment

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 group, 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.

DRUG

Placebo

Placebo: 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.

Trial Locations (1)

35516

Mansoura University Hospital, Al Mansurah

All Listed Sponsors
collaborator

Mansoura University

OTHER

collaborator

Stanley Medical Research Institute

OTHER

lead

University of Pittsburgh

OTHER

NCT02011750 - Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia | Biotech Hunter | Biotech Hunter