ID

20794

Description

Depression in Older Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00643162

Link

https://clinicaltrials.gov/show/NCT00643162

Keywords

Versions (1)
  1. 3/18/17 3/18/17 -
Uploaded on

March 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00643162

English

Eligibility Depression NCT00643162

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00643162
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. > 60 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. unipolar major depression as defined by structured clinical interaction dsm-iv (scid)
Description

Unipolar major depression

Data type

boolean

Alias
UMLS CUI [1]
C1269683
3. ham-d score of > 17 (21-item scale)]]
Description

Hamilton Rating Scale

Data type

boolean

Alias
UMLS CUI [1]
C0451203
4. not taking antidepressants for at least two weeks, 2 months for fluoxetine and maois]]
Description

Antidepressive Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0087111
5. capable of giving informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unable to provide informed consent (e.g. severe cognitive impairment)
Description

Unable to give informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
2. acute medical condition or exacerbation of chronic medical condition associated with significant distress (pain, protracted fevers, etc.) and requiring active medical treatment.
Description

Medical condition requiring medical treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0087111
3. high risk of suicide or violence as assessed by the investigator
Description

High risk of suicide

Data type

boolean

Alias
UMLS CUI [1]
C1271074
4. current or past history of psychosis or bipolar disorder
Description

Psychosis or bipolar disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0005586
5. use of psychotropic medication and/or psychotherapy outside of the study
Description

Psychotropic medication and/or psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0033968
6. (exposure to treatment of fluoxetine or maois in the previous two months; chronic use of benzodiazepine and non-benzodiazepine sedatives, antipsychotics, psychostimulants, mood stabilizing agents, codeine, steroids, anti-inflammatory agents.
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013216
7. alternative medicine use in the preceding 30 days (e.g. acupuncture, herbs, etc.)
Description

Alternative medicine

Data type

boolean

Alias
UMLS CUI [1]
C0002346
8. history of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
Description

Contraindication to massage

Data type

boolean

Alias
UMLS CUI [1,1]
C0024875
UMLS CUI [1,2]
C1301624
9. diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders;
Description

Mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
10. mmse less than 22
Description

MMSE

Data type

boolean

Alias
UMLS CUI [1]
C0451306
11. alzheimer's disease assessment scale-cognitive subscale ³ greater than 12
Description

Alzheimer's disease assessment

Data type

boolean

Alias
UMLS CUI [1]
C0002395
12. current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
13. unstable medical or neurological conditions that are likely to interfere with the treatment of depression
Description

Unstable status

Data type

boolean

Alias
UMLS CUI [1]
C0443343
14. currently on psychotropic medications including antidepressants or neuroleptics
Description

Psychotropic pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033978
15. active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
Description

Safety issue

Data type

boolean

Alias
UMLS CUI [1]
C2911688
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Similar models

Eligibility Depression NCT00643162

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00643162
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. > 60 years of age
boolean
C0001779 (UMLS CUI [1])
Unipolar major depression
Item
2. unipolar major depression as defined by structured clinical interaction dsm-iv (scid)
boolean
C1269683 (UMLS CUI [1])
Hamilton Rating Scale
Item
3. ham-d score of > 17 (21-item scale)]]
boolean
C0451203 (UMLS CUI [1])
Antidepressive Therapy
Item
4. not taking antidepressants for at least two weeks, 2 months for fluoxetine and maois]]
boolean
C0003289 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Informed Consent
Item
5. capable of giving informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unable to give informed consent
Item
1. unable to provide informed consent (e.g. severe cognitive impairment)
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Medical condition requiring medical treatment
Item
2. acute medical condition or exacerbation of chronic medical condition associated with significant distress (pain, protracted fevers, etc.) and requiring active medical treatment.
boolean
C0012634 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
High risk of suicide
Item
3. high risk of suicide or violence as assessed by the investigator
boolean
C1271074 (UMLS CUI [1])
Psychosis or bipolar disorder
Item
4. current or past history of psychosis or bipolar disorder
boolean
C0033975 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
Psychotropic medication and/or psychotherapy
Item
5. use of psychotropic medication and/or psychotherapy outside of the study
boolean
C0033978 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
Pharmacotherapy
Item
6. (exposure to treatment of fluoxetine or maois in the previous two months; chronic use of benzodiazepine and non-benzodiazepine sedatives, antipsychotics, psychostimulants, mood stabilizing agents, codeine, steroids, anti-inflammatory agents.
boolean
C0013216 (UMLS CUI [1])
Alternative medicine
Item
7. alternative medicine use in the preceding 30 days (e.g. acupuncture, herbs, etc.)
boolean
C0002346 (UMLS CUI [1])
Contraindication to massage
Item
8. history of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
boolean
C0024875 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Mental disorder
Item
9. diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders;
boolean
C0004936 (UMLS CUI [1])
MMSE
Item
10. mmse less than 22
boolean
C0451306 (UMLS CUI [1])
Alzheimer's disease assessment
Item
11. alzheimer's disease assessment scale-cognitive subscale ³ greater than 12
boolean
C0002395 (UMLS CUI [1])
Substance Use Disorder
Item
12. current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months
boolean
C0038586 (UMLS CUI [1])
Unstable status
Item
13. unstable medical or neurological conditions that are likely to interfere with the treatment of depression
boolean
C0443343 (UMLS CUI [1])
Psychotropic pharmacotherapy
Item
14. currently on psychotropic medications including antidepressants or neuroleptics
boolean
C0033978 (UMLS CUI [1])
Safety issue
Item
15. active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
boolean
C2911688 (UMLS CUI [1])
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