ID

24588

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00853346

Palabras clave

Versiones (1)
  1. 8/8/17 8/8/17 -
Subido en

8 de agosto de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Major Depressive Disorder NCT00853346

Inglés

Eligibility Major Depressive Disorder NCT00853346

1 formularios  
Inclusion Criteria
Descripción

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:
Descripción

Major Depressive Disorder

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

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

Parkinson Disease Principal diagnosis | Criteria Fulfill Major Depressive Disorder

Tipo de datos

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
Descripción

Antiparkinson Agents Stable | Change of medication Absent

Tipo de datos

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
Descripción

Antidepressive Agents Dose Stable | Drug dose unchanged

Tipo de datos

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
Descripción

Age

Tipo de datos

boolean

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

Hamilton Depression Rating Scale 17 Item Questionnaire

Tipo de datos

boolean

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

Mini-mental state examination

Tipo de datos

boolean

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

Study Subject Participation Status Willing

Tipo de datos

boolean

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

Exclusion Criteria

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

Criteria Fulfill

Tipo de datos

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
Descripción

At risk for suicide Serious | Homicide Risk Serious

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Dementia

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

Psychosocial intervention strategy Specific Depressive disorder | Couples counseling allowed

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Eligibility Major Depressive Disorder NCT00853346

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial