ID

18742

Description

The Effect of Switching to Aripiprazole on Heart Health in Overweight and Obese Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00222833

Link

https://clinicaltrials.gov/show/NCT00222833

Keywords

Versions (1)
  1. 11/18/16 11/18/16 -
Uploaded on

November 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Overweight NCT00222833

English

Eligibility Overweight NCT00222833

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00222833
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ages 18-65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
outpatients and stable partial hospital patients
Description

Outpatients | Hospital patients Partial Stable

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0021562
UMLS CUI [2,2]
C0728938
UMLS CUI [2,3]
C0205360
diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) diagnosis of schizophrenia or schizoaffective disorder
Description

Schizophrenia | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
no psychiatric hospitalization in 30 days prior to study start
Description

psychiatric hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0748061
partially remitted patients with a panss score below 100 at screening
Description

Patient in partial remission | Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C1562651
UMLS CUI [2]
C0451383
currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
Description

Antipsychotic Agent Singular Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
Description

Psychotropic Drugs Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
bmi greater than 26
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
ability to provide informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mental retardation
Description

Mental Retardation

Data type

boolean

Alias
UMLS CUI [1]
C0025362
current treatment with clozapine
Description

Clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
Description

Weight Reduction Program | Weight reduction regimen pharmacological

Data type

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0311130
UMLS CUI [2,2]
C0205464
serious or unstable medical illness
Description

Illness Serious | Illness Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
female patients who are pregnant, lactating, or plan to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.
Description

Ketoconazole | Quinidine | Carbamazepine

Data type

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0034414
UMLS CUI [3]
C0006949
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Similar models

Eligibility Overweight NCT00222833

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT00222833
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female subjects ages 18-65 years
boolean
C0001779 (UMLS CUI [1])
Outpatients | Hospital patients Partial Stable
Item
outpatients and stable partial hospital patients
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2,1])
C0728938 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Schizophrenia | Schizoaffective Disorder
Item
diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) diagnosis of schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
psychiatric hospitalization
Item
no psychiatric hospitalization in 30 days prior to study start
boolean
C0748061 (UMLS CUI [1])
Patient in partial remission | Positive and negative syndrome scale
Item
partially remitted patients with a panss score below 100 at screening
boolean
C1562651 (UMLS CUI [1])
C0451383 (UMLS CUI [2])
Antipsychotic Agent Singular Dose Stable
Item
currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
boolean
C0040615 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Psychotropic Drugs Dose Stable
Item
currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
boolean
C0033978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Body mass index
Item
bmi greater than 26
boolean
C1305855 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
ability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental Retardation
Item
mental retardation
boolean
C0025362 (UMLS CUI [1])
Clozapine
Item
current treatment with clozapine
boolean
C0009079 (UMLS CUI [1])
Weight Reduction Program | Weight reduction regimen pharmacological
Item
currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
boolean
C3179079 (UMLS CUI [1])
C0311130 (UMLS CUI [2,1])
C0205464 (UMLS CUI [2,2])
Illness Serious | Illness Unstable
Item
serious or unstable medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female patients who are pregnant, lactating, or plan to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Ketoconazole | Quinidine | Carbamazepine
Item
concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.
boolean
C0022625 (UMLS CUI [1])
C0034414 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
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