ID

35936

Beschreibung

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

Stichworte

Versionen (1)
  1. 04.04.19 04.04.19 -
Rechteinhaber

University of Pittsburgh

Hochgeladen am

4. April 2019

DOI

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Lizenz

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

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient signed the written informed consent
Beschreibung

Informed consent

Datentyp

boolean

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

Age and gender

Datentyp

boolean

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

Diagnosis

Datentyp

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.
Beschreibung

Illness duration

Datentyp

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
Beschreibung

Pharmaceutical treatment

Datentyp

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.
Beschreibung

PNNS-Scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Substance abuse / dependence

Datentyp

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
Beschreibung

Neurological illnesses

Datentyp

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
Beschreibung

Unstable medical conditions

Datentyp

boolean

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

Pregnancy or breastfeeding

Datentyp

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.
Beschreibung

DEP = Depakote = Sodium Valproate

Datentyp

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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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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