ID

13688

Description

Halifax Treatment Refractory Depression Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01141426

Link

https://clinicaltrials.gov/show/NCT01141426

Keywords

Versions (1)
  1. 2/28/16 2/28/16 -
Uploaded on

February 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT01141426

English

Eligibility Depression NCT01141426

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01141426
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 - 65 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must identify depression as their primary problem (rather than being secondary to other mental health diagnosis).
Description

primary disorders depression

Data type

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C0011581
any dsm-iv diagnosis of major depression as assessed by the mini neuropsychiatric interview plus (m.i.n.i. plus) at time of research intake interview.
Description

dsm-iv; major depression

Data type

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C1269683
patients will have had at least one treatment trial of antidepressants at an acceptable therapeutic dose (length ≥ 6 weeks) for the current depressive episode without adequate response (score on the hamilton rating scale for depression ≥ 16 ) at time of screening interview.
Description

antidepressant; Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0451203
patients will not have started new medications in the previous ≥ 6 weeks, or have received psychotherapy treatment in the 12 months prior to being invited to participate in the study.
Description

psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
participants will agree to video-taped sessions and will consent to the investigator accessing their information in clinical files and hospital database (e.g., medications, number of visits to health care professionals).
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
psychotic depression, bipolar depression, substance dependence, severe cluster a or b personality disorders, active suicidality, or cognitive impairment: such that patients require an intervention other than psychotherapy (as per the current protocol for the experimental treatment arm) or patients unable to give consent to treatment.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients with depression due to a general medical condition or secondary to a comorbid mental health or psychosocial condition will be excluded.
Description

Secondary disease depression

Data type

boolean

Alias
UMLS CUI [1,1]
C0277555
UMLS CUI [1,2]
C0011581
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Similar models

Eligibility Depression NCT01141426

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01141426
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patients aged 18 - 65 years.
boolean
C0001779 (UMLS CUI [1])
primary disorders depression
Item
patients must identify depression as their primary problem (rather than being secondary to other mental health diagnosis).
boolean
C0277554 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
dsm-iv; major depression
Item
any dsm-iv diagnosis of major depression as assessed by the mini neuropsychiatric interview plus (m.i.n.i. plus) at time of research intake interview.
boolean
C0220952 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
antidepressant; Hamilton rating scale for depression
Item
patients will have had at least one treatment trial of antidepressants at an acceptable therapeutic dose (length ≥ 6 weeks) for the current depressive episode without adequate response (score on the hamilton rating scale for depression ≥ 16 ) at time of screening interview.
boolean
C0003289 (UMLS CUI [1])
C0451203 (UMLS CUI [2])
psychotherapy
Item
patients will not have started new medications in the previous ≥ 6 weeks, or have received psychotherapy treatment in the 12 months prior to being invited to participate in the study.
boolean
C0033968 (UMLS CUI [1])
informed consent
Item
participants will agree to video-taped sessions and will consent to the investigator accessing their information in clinical files and hospital database (e.g., medications, number of visits to health care professionals).
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited Comorbidity
Item
psychotic depression, bipolar depression, substance dependence, severe cluster a or b personality disorders, active suicidality, or cognitive impairment: such that patients require an intervention other than psychotherapy (as per the current protocol for the experimental treatment arm) or patients unable to give consent to treatment.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Secondary disease depression
Item
patients with depression due to a general medical condition or secondary to a comorbid mental health or psychosocial condition will be excluded.
boolean
C0277555 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
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