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Completed

NCT Number: NCT02011750

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

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).

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Key information

Conditions

Toxoplasmosis Coccidiosis Infections Mental Disorders Parasitic Diseases Protozoan Infections Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University Hospital

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Valproate treatment

Drug

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 names: Depakote

Placebo

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Social Functioning assessed via the Short Form

    Time frame: Social functioning will be assessed during week 16

    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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Mansoura University
  • Stanley Medical Research Institute

Registry information

Official study title

Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2013
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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