ID

24588

Beschreibung

Psychosocial Treatment of Depression in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00853346

Link

https://clinicaltrials.gov/show/NCT00853346

Stichworte

Versionen (1)
  1. 08.08.17 08.08.17 -
Hochgeladen am

8. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00853346

Englisch

Eligibility Major Depressive Disorder NCT00853346

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
in addition to the dsm-iv diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects with a primary diagnosis of pd who also currently meet dsm-iv criteria for mdd
Beschreibung

Parkinson Disease Principal diagnosis | Criteria Fulfill Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0332137
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C1269683
subjects must be stable on their anti-parkinson treatment, as defined by no medication changes over the past 6 weeks
Beschreibung

Antiparkinson Agents Stable | Change of medication Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0580105
UMLS CUI [2,2]
C0332197
subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
Beschreibung

Antidepressive Agents Dose Stable | Drug dose unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0678766
UMLS CUI [2,2]
C0442739
men or women 40-80 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
hamd-17 scores > 14 at screen visit
Beschreibung

Hamilton Depression Rating Scale 17 Item Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1]
C3639712
score of 25 or greater on the mini-mental status examination
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
willing to come to mgh for screening and study participation
Beschreibung

Study Subject Participation Status Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients meeting any of the following criteria are to be excluded from the study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
Beschreibung

At risk for suicide Serious | Homicide Risk Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205404
patients who would not be appropriate for a delayed cbt control due to the severity of their depression based on clinical judgment as well as hamd-17 scores > 28
Beschreibung

Patients Inappropriate Cognitive Therapy Delayed | Hamilton Depression Rating Scale 17 Item Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0009244
UMLS CUI [1,4]
C0205421
UMLS CUI [2]
C3639712
the following dsm-iv diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) mdd with psychotic features
Beschreibung

Substance Use Disorders | Alcoholic Intoxication, Chronic | Schizophrenia | Delusional disorder | Psychotic Disorders | Bipolar Disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0011251
UMLS CUI [5]
C0033975
UMLS CUI [6]
C0005586
UMLS CUI [7]
C0743080
subjects who meet dsm-iv criteria for dementia
Beschreibung

Dementia

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
Beschreibung

Medical condition Unstable Severe | Hospitalization Required | Congestive heart failure Severe | Hospital admission Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C1708385
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0184666
UMLS CUI [4,2]
C0332185
subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
Beschreibung

Psychosocial intervention strategy Specific Depressive disorder | Couples counseling allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0454041
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0011581
UMLS CUI [2,1]
C1160830
UMLS CUI [2,2]
C0683607
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT00853346

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
in addition to the dsm-iv diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
boolean
C1269683 (UMLS CUI [1])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Parkinson Disease Principal diagnosis | Criteria Fulfill Major Depressive Disorder
Item
subjects with a primary diagnosis of pd who also currently meet dsm-iv criteria for mdd
boolean
C0030567 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C1269683 (UMLS CUI [2,3])
Antiparkinson Agents Stable | Change of medication Absent
Item
subjects must be stable on their anti-parkinson treatment, as defined by no medication changes over the past 6 weeks
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0580105 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Antidepressive Agents Dose Stable | Drug dose unchanged
Item
subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0678766 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Age
Item
men or women 40-80 years of age
boolean
C0001779 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
hamd-17 scores > 14 at screen visit
boolean
C3639712 (UMLS CUI [1])
Mini-mental state examination
Item
score of 25 or greater on the mini-mental status examination
boolean
C0451306 (UMLS CUI [1])
Study Subject Participation Status Willing
Item
willing to come to mgh for screening and study participation
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients meeting any of the following criteria are to be excluded from the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
At risk for suicide Serious | Homicide Risk Serious
Item
subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Patients Inappropriate Cognitive Therapy Delayed | Hamilton Depression Rating Scale 17 Item Questionnaire
Item
patients who would not be appropriate for a delayed cbt control due to the severity of their depression based on clinical judgment as well as hamd-17 scores > 28
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0009244 (UMLS CUI [1,3])
C0205421 (UMLS CUI [1,4])
C3639712 (UMLS CUI [2])
Substance Use Disorders | Alcoholic Intoxication, Chronic | Schizophrenia | Delusional disorder | Psychotic Disorders | Bipolar Disorder | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE
Item
the following dsm-iv diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) mdd with psychotic features
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0011251 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0005586 (UMLS CUI [6])
C0743080 (UMLS CUI [7])
Dementia
Item
subjects who meet dsm-iv criteria for dementia
boolean
C0497327 (UMLS CUI [1])
Medical condition Unstable Severe | Hospitalization Required | Congestive heart failure Severe | Hospital admission Recent
Item
severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1708385 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0184666 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Psychosocial intervention strategy Specific Depressive disorder | Couples counseling allowed
Item
subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
boolean
C0454041 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C1160830 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
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