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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii

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).

Detailed Summary:
Sponsor: University of Pittsburgh

Current Primary Outcome:

  • Clinical Severity [ Time Frame: Clinical severity will be assessed during week 20 of the study. ]
    Clinical Severity will be measured by the Positive and Negative Syndrome Scale (PANSS),a 7 point rating scale for 30 psychopathological items based on interviews or reports.
  • Cognitive Domains assessed via the Arabic version of the Penn CNB [ Time Frame: Cognitive domains wil be measured in week 16 of the study ]
    Cognitive domains will be assessed using the Arabic version of the Penn Computerized Neuropsychological Battery (CNB), which includes cognitive measures that distinguish SZ cases and relatives from controls. Accuracy and response time are recorded.
  • Social Function assessed via the Quality of Life Scale [ Time Frame: Social functioing will be assessed during week during week 16. ]
    Overall Social function will be measured by the Quality of Life Scale, which measures interpersonal, social and occupational functioning.
  • Cognitive domains assessed via Trails Making Test [ Time Frame: Cognitive domains will be assessed in week 16 of the study ]
    Cognitive domains will be assessed using the Trails Making Test, a neuropsychological test of attention and task switching.
  • Social Function -assessed via the GAF scale [ Time Frame: Social functioning will be assessed during week 16 ]
    Social functioning will be assessed using the Global Assessment of Functioning (GAF), a global measure of function and symptom severity.

  • Original Primary Outcome: Same as current

    Current Secondary Outcome: Side effects [ Time Frame: Side effects will be measured during week 20 of the study. ]

    Participants will be monitored for adverse reactions to study medication through week 20.


    Original Secondary Outcome: Same as current

    Information By: University of Pittsburgh

    Dates:
    Date Received: June 21, 2013
    Date Started: March 2013
    Date Completion: October 2017
    Last Updated: October 24, 2016
    Last Verified: October 2016