DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 Severity

Cognitive 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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017