ID

37169

Description

Oxytocin as Adjunctive Therapy for Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01699997

Link

https://clinicaltrials.gov/show/NCT01699997

Keywords

Versions (1)
  1. 7/5/19 7/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01699997

English

Eligibility Schizophrenia NCT01699997

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of sz, according to dsm-iv criteria, for at least one year, evaluated with scid/p
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
a minimum panss total score of 55 (indicating moderate severity, due to ongoing ap treatment) .
Description

PANSS Clinical Classification | Antipsychotic Agents

Data type

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2]
C0040615
a minimum cgi-s score of 4
Description

Clinical global impression scale

Data type

boolean

Alias
UMLS CUI [1]
C3639708
age between 18 and 45 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a disorder duration of no longer than 10 years
Description

Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
women of childbearing age must test negative for pregnancy at the time of enrolment.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
all patients must:
Description

Patients All

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0444868
be on a therapeutic dose of a sga (or a maximum 2 sgas) with no major dose changes for at least 4 weeks.
Description

Antipsychotic Agents Generation second | Antipsychotic Agents Dose Therapeutic | Antipsychotic Agents Quantity | Change in drug dosage Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0302350
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0420247
UMLS CUI [4,2]
C0332197
have the ability to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be able to use a nasal spray
Description

Use of Nasal spray

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C2825048
reside in the service catchment area
Description

Residence Nearby

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
show evidence of no alcohol or substance dependence in the last year
Description

Substance Dependence Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of mental retardation
Description

Mental Retardation

Data type

boolean

Alias
UMLS CUI [1]
C0025362
diagnosis of organic mental disorder
Description

Organic mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0029227
history of no response to treatment with clozapine
Description

Clozapine Response Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0332197
history of hypersensitivity to oxt or vehicle
Description

Oxytocin allergy | Hypersensitivity Oxytocin vehicle

Data type

boolean

Alias
UMLS CUI [1]
C0571729
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0030095
UMLS CUI [2,3]
C0042444
alcohol or substance dependence in the last year
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
Description

Allergic rhinitis

Data type

boolean

Alias
UMLS CUI [1]
C2607914
being pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
having given birth in the past 6 months or breast-feeding in the past 3 months
Description

Birth | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0005615
UMLS CUI [2]
C0006147
low literacy as indicated by an inability to read and understand the consent form
Description

Low-level literacy | Lacking Able to read Consent Form | Consent Form Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1]
C1401894
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0009797
UMLS CUI [3,1]
C0009797
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C1299582
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Similar models

Eligibility Schizophrenia NCT01699997

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients with a diagnosis of sz, according to dsm-iv criteria, for at least one year, evaluated with scid/p
boolean
C0036341 (UMLS CUI [1])
PANSS Clinical Classification | Antipsychotic Agents
Item
a minimum panss total score of 55 (indicating moderate severity, due to ongoing ap treatment) .
boolean
C4086747 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
Clinical global impression scale
Item
a minimum cgi-s score of 4
boolean
C3639708 (UMLS CUI [1])
Age
Item
age between 18 and 45 years
boolean
C0001779 (UMLS CUI [1])
Disease length
Item
a disorder duration of no longer than 10 years
boolean
C0872146 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
women of childbearing age must test negative for pregnancy at the time of enrolment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Patients All
Item
all patients must:
boolean
C0030705 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Antipsychotic Agents Generation second | Antipsychotic Agents Dose Therapeutic | Antipsychotic Agents Quantity | Change in drug dosage Absent
Item
be on a therapeutic dose of a sga (or a maximum 2 sgas) with no major dose changes for at least 4 weeks.
boolean
C0040615 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0302350 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0420247 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Informed Consent
Item
have the ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Use of Nasal spray
Item
be able to use a nasal spray
boolean
C1524063 (UMLS CUI [1,1])
C2825048 (UMLS CUI [1,2])
Residence Nearby
Item
reside in the service catchment area
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
Substance Dependence Absent
Item
show evidence of no alcohol or substance dependence in the last year
boolean
C0038580 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Mental Retardation
Item
diagnosis of mental retardation
boolean
C0025362 (UMLS CUI [1])
Organic mental disorder
Item
diagnosis of organic mental disorder
boolean
C0029227 (UMLS CUI [1])
Clozapine Response Absent
Item
history of no response to treatment with clozapine
boolean
C0009079 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Oxytocin allergy | Hypersensitivity Oxytocin vehicle
Item
history of hypersensitivity to oxt or vehicle
boolean
C0571729 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0030095 (UMLS CUI [2,2])
C0042444 (UMLS CUI [2,3])
Substance Dependence
Item
alcohol or substance dependence in the last year
boolean
C0038580 (UMLS CUI [1])
Allergic rhinitis
Item
presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
boolean
C2607914 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
being pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Birth | Breast Feeding
Item
having given birth in the past 6 months or breast-feeding in the past 3 months
boolean
C0005615 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Low-level literacy | Lacking Able to read Consent Form | Consent Form Comprehension Unable
Item
low literacy as indicated by an inability to read and understand the consent form
boolean
C1401894 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0009797 (UMLS CUI [2,3])
C0009797 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
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