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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Mansoura University
Stanley Medical Research Institute
Information provided by (Responsible Party):
Hader Mansour, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02011750
First received: June 21, 2013
Last updated: December 9, 2013
Last verified: December 2013

June 21, 2013
December 9, 2013
March 2013
February 2015   (final data collection date for primary outcome measure)
  • Clinical Severity [ Time Frame: Clinical severity will be assessed during week 20 of the study. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Social functioning will be assessed using the Global Assessment of Functioning (GAF), a global measure of function and symptom severity.
  • Social Functioning assessed via the Short Form [ Time Frame: Social functioning will be assessed during week 16 ] [ Designated as safety issue: No ]
    Social functioning will be assessed via the Short Form, a multi-item scale that consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
Same as current
Complete list of historical versions of study NCT02011750 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: Side effects will be measured during week 20 of the study. ] [ Designated as safety issue: Yes ]
Participants will be monitored for adverse reactions to study medication through week 20.
Same as current
Not Provided
Not Provided
 
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii

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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Toxoplasmosis
  • Schizophrenia
  • 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.
    Other Name: Depakote
  • 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.
  • Experimental: 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 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.
    Interventions:
    • Drug: Sodium Valproate treatment
    • Drug: Placebo
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
March 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT02011750
PRO12020320
Yes
Hader Mansour, MD, University of Pittsburgh
University of Pittsburgh
  • Mansoura University
  • Stanley Medical Research Institute
Principal Investigator: Hader Mansour, MD University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP