Clinical trial NCT02011750: Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Official title: Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Toxoplasmosis
Schizophrenia
Keywords: schizophrenia
toxoplasmosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Mansoura University
name: Stanley Medical Research Institute
First posted: 2013-12-13
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Clinical Severity
timeFrame: Clinical severity will be assessed during week 20 of the study.
measure: Cognitive Domains assessed via the Arabic version of the Penn CNB
timeFrame: Cognitive domains wil be measured in week 16 of the study
measure: Social Function assessed via the Quality of Life Scale
timeFrame: Social functioing will be assessed during week during week 16.
measure: Cognitive domains assessed via Trails Making Test
timeFrame: Cognitive domains will be assessed in week 16 of the study
measure: Social Function -assessed via the GAF scale
timeFrame: Social functioning will be assessed during week 16
measure: Social Functioning assessed via the Short Form
timeFrame: Social functioning will be assessed during week 16
Secondary outcomes:
measure: Side effects
timeFrame: Side effects will be measured during week 20 of the study.
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: University of Pittsburgh
name: Hader Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References: