ID

35936

Description

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. ODM derived from: https://clinicaltrials.gov/show/NCT02011750

Link

https://clinicaltrials.gov/show/NCT02011750

Keywords

Versions (1)
  1. 4/4/19 4/4/19 -
Copyright Holder

University of Pittsburgh

Uploaded on

April 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia NCT02011750

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient signed the written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Patient is an adult man or woman (aged 18-50 years)
Description

Age and gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Patient with diagnosed schizophrenia or schizoaffective disorder (DSM IV)
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C0220952
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0036337
UMLS CUI [2,3]
C0220952
Patient is less than 5 years (since onset of psychosis) ill.
Description

Illness duration

Data type

boolean

Alias
UMLS CUI [1,1]
C3176590
UMLS CUI [1,2]
C0033975
Patient is on a stable dose of an antipsychotic for at least a month
Description

Pharmaceutical treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Patient scores 4 or more on at least one item of the positive and negative syndrome scale.
Description

PNNS-Scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Substance abuse in the past month/dependence past 6 months
Description

Substance abuse / dependence

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0262926
Patient with history of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy
Description

Neurological illnesses

Data type

boolean

Alias
UMLS CUI [1]
C2186518
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0521116
UMLS CUI [3]
C0025362
UMLS CUI [4]
C0014544
Patient with medical conditions that are judged by the consulting internist and research staff to be unstable
Description

Unstable medical conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
Patient being pregnant or breast-feeding
Description

Pregnancy or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Patient with known allergy or serious adverse event to DEP, received chlorpromazine, trimethoprim or DEP for up to 6 months prior to study entry.
Description

DEP = Depakote = Sodium Valproate

Data type

boolean

Alias
UMLS CUI [1,1]
C0719751
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0719751
UMLS CUI [2,2]
C1519255
UMLS CUI [3,1]
C0719751
UMLS CUI [3,2]
C2826667
UMLS CUI [4,1]
C0008286
UMLS CUI [4,2]
C2826667
UMLS CUI [5,1]
C0041041
UMLS CUI [5,2]
C2826667
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
Patient signed the written informed consent
boolean
C0021430 (UMLS CUI [1])
Age and gender
Item
Patient is an adult man or woman (aged 18-50 years)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diagnosis
Item
Patient with diagnosed schizophrenia or schizoaffective disorder (DSM IV)
boolean
C0011900 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,3])
C0011900 (UMLS CUI [2,1])
C0036337 (UMLS CUI [2,2])
C0220952 (UMLS CUI [2,3])
Illness duration
Item
Patient is less than 5 years (since onset of psychosis) ill.
boolean
C3176590 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
Pharmaceutical treatment
Item
Patient is on a stable dose of an antipsychotic for at least a month
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
PNNS-Scale
Item
Patient scores 4 or more on at least one item of the positive and negative syndrome scale.
boolean
C0451383 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Substance abuse / dependence
Item
Substance abuse in the past month/dependence past 6 months
boolean
C0038586 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Neurological illnesses
Item
Patient with history of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy
boolean
C2186518 (UMLS CUI [1])
C0027765 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0025362 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
Unstable medical conditions
Item
Patient with medical conditions that are judged by the consulting internist and research staff to be unstable
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Pregnancy or breastfeeding
Item
Patient being pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraindication to DEP
Item
Patient with known allergy or serious adverse event to DEP, received chlorpromazine, trimethoprim or DEP for up to 6 months prior to study entry.
boolean
C0719751 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0719751 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0719751 (UMLS CUI [3,1])
C2826667 (UMLS CUI [3,2])
C0008286 (UMLS CUI [4,1])
C2826667 (UMLS CUI [4,2])
C0041041 (UMLS CUI [5,1])
C2826667 (UMLS CUI [5,2])
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