ID

30602

Description

Efficacy and Feasibility of a Personalized Treatment for Depression With Co-Occurring Anxiety; ODM derived from: https://clinicaltrials.gov/show/NCT00930293

Lien

https://clinicaltrials.gov/show/NCT00930293

Mots-clés

Versions (1)
  1. 17/06/2018 17/06/2018 -
Détendeur de droits

see clinical trials.gov

Téléchargé le

17 juin 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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Eligibility Depression NCT00930293

Anglais

Eligibility Depression NCT00930293

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00930293
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
currently in an episode of nonpsychotic major depression, as defined by the dsm-iv and documented by both the structured clinical interview for axis i, dsm-iv disorders (scid) and by a rating of greater than 15 on the 25-item hamilton rating scale for depression (hrsd)
Description

Major Depressive Disorder, DSM-IV, Axis I diagnosis, Hamilton rating scale for depression

Type de données

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0220952
UMLS CUI [1,3]
C0270287
UMLS CUI [1,4]
C0451203
panic spectrum risk category of at least 7, as defined by the panic-agoraphobic spectrum self-report (pas-sr), last month version
Description

Panic disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0030319
not currently receiving effective treatment
Description

Antidepressive Agents, Effectiveness, No

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C1298908
participants with suicidal ideation are eligible as long as outpatient treatment is deemed safe.
Description

Suicidal, Outpatient procedure, Effective

Type de données

boolean

Alias
UMLS CUI [1,1]
C0438696
UMLS CUI [1,2]
C1299353
UMLS CUI [1,3]
C1704419
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of manic or hypomanic episode(s)
Description

Manic episode, Previous; hypomanic episode, Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0349208
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1396834
UMLS CUI [2,2]
C0205156
history of schizophrenia or schizoaffective disorder
Description

Schizophrenia, Previous; Schizoaffective Disorder, Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0036337
UMLS CUI [2,2]
C0205156
mood disorder due to a general medical condition or induced by substance use
Description

Mood Disorders Due to Disease; Mood Disorders Due to Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525045
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C0525045
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0038586
presence of psychosis
Description

Psychotic Disorders, Present

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0150312
current pregnancy or plans to become pregnant
Description

Pregnancy; Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
of anorexia nervosa or bulimia nervosa (this does not include an eating disorder not otherwise specified [nos])
Description

Anorexia Nervosa, primary disorders, current; Bulimia Nervosa, primary disorders, current

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003125
UMLS CUI [1,2]
C0277554
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C2267227
UMLS CUI [2,2]
C0277554
UMLS CUI [2,3]
C0521116
current primary diagnosis of severe obsessive-compulsive disorder (ocd), as determined by clinician evaluation of symptom severity and temporal onset of symptoms
Description

Obsessive-Compulsive Disorder, Severe, primary disorders, Current

Type de données

boolean

Alias
UMLS CUI [1,1]
C0028768
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0277554
UMLS CUI [1,4]
C0521116
drug or alcohol abuse or dependence within the past 3 months (participants with episodic abuse related to mood episodes will not be excluded)
Description

Substance Use Disorders, Previous; Substance Dependence, Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0205156
satisfies full dsm-iv criteria for antisocial personality disorder, as determined by scid-ii evaluation
Description

Antisocial Personality Disorder, DSM-IV

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003431
UMLS CUI [1,2]
C0220952
requires inpatient treatment because of suicidal risk or (current suicidal thinking or parasuicidal behavior is not exclusionary if, in clinician judgment, it can be managed on an outpatient basis)
Description

Suicidal,Therapeutic procedure, inpatient; Psychotic symptom, Therapeutic procedure, inpatient

Type de données

boolean

Alias
UMLS CUI [1,1]
C0438696
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0021562
UMLS CUI [2,1]
C0871189
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0021562
any of the following medical conditions:
Description

ID.15

Type de données

boolean

1. an index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.
Description

Depressive episode Due to Prescribed medications

Type de données

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3166216
2. presence of significant uncontrolled medical illness including cardiovascular disorder, kidney or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease (stable medical conditions such as well-controlled diabetes or hiv positive status are not exclusionary provided the participant meets other inclusion and exclusion criteria)
Description

Illness (finding), Significant, Uncontrolled, Present

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0205318
UMLS CUI [1,4]
C0150312
3. current treatment with a pharmacologic, over-the-counter, or herbal therapy for depression or anxiety (unless the participant wishes to discontinue an ineffective treatment)
Description

Depressive disorder, Current Therapy, Pharmacotherapy; Depressive disorder, Current Therapy,Over The Counter Pharmaceutical Preparations; Depressive disorder, Current Therapy, Herbal Drugs; Anxiety, Current Therapy, Pharmacotherapy; Anxiety, Current Therapy, Over The Counter Pharmaceutical Preparations; Anxiety, Current Therapy, Herbal Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C2827774
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C2827774
UMLS CUI [2,3]
C2709201
UMLS CUI [2,4]
C0013227
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C2827774
UMLS CUI [3,3]
C1360419
UMLS CUI [4,1]
C0003467
UMLS CUI [4,2]
C2827774
UMLS CUI [4,3]
C0013216
UMLS CUI [5,1]
C0003467
UMLS CUI [5,2]
C2827774
UMLS CUI [5,3]
C2709201
UMLS CUI [5,4]
C0013227
UMLS CUI [6,1]
C0003467
UMLS CUI [6,2]
C2827774
UMLS CUI [6,3]
C1360419
history of poor or failed treatment response to an adequate dose and duration of citalopram
Description

Poor response to treatment, Citalopram, Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C1320680
UMLS CUI [1,2]
C0008845
UMLS CUI [1,3]
C0205156
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Similar models

Eligibility Depression NCT00930293

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00930293
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder, DSM-IV, Axis I diagnosis, Hamilton rating scale for depression
Item
currently in an episode of nonpsychotic major depression, as defined by the dsm-iv and documented by both the structured clinical interview for axis i, dsm-iv disorders (scid) and by a rating of greater than 15 on the 25-item hamilton rating scale for depression (hrsd)
boolean
C1269683 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0270287 (UMLS CUI [1,3])
C0451203 (UMLS CUI [1,4])
Panic disorder
Item
panic spectrum risk category of at least 7, as defined by the panic-agoraphobic spectrum self-report (pas-sr), last month version
boolean
C0030319 (UMLS CUI [1])
Antidepressive Agents, Effectiveness, No
Item
not currently receiving effective treatment
boolean
C0003289 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
Suicidal, Outpatient procedure, Effective
Item
participants with suicidal ideation are eligible as long as outpatient treatment is deemed safe.
boolean
C0438696 (UMLS CUI [1,1])
C1299353 (UMLS CUI [1,2])
C1704419 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Manic episode, Previous; hypomanic episode, Previous
Item
history of manic or hypomanic episode(s)
boolean
C0349208 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1396834 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Schizophrenia, Previous; Schizoaffective Disorder, Previous
Item
history of schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0036337 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Mood Disorders Due to Disease; Mood Disorders Due to Substance Use Disorders
Item
mood disorder due to a general medical condition or induced by substance use
boolean
C0525045 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0525045 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2,3])
Psychotic Disorders, Present
Item
presence of psychosis
boolean
C0033975 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Pregnancy; Pregnancy, Planned
Item
current pregnancy or plans to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Anorexia Nervosa, primary disorders, current; Bulimia Nervosa, primary disorders, current
Item
of anorexia nervosa or bulimia nervosa (this does not include an eating disorder not otherwise specified [nos])
boolean
C0003125 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C2267227 (UMLS CUI [2,1])
C0277554 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Obsessive-Compulsive Disorder, Severe, primary disorders, Current
Item
current primary diagnosis of severe obsessive-compulsive disorder (ocd), as determined by clinician evaluation of symptom severity and temporal onset of symptoms
boolean
C0028768 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Substance Use Disorders, Previous; Substance Dependence, Previous
Item
drug or alcohol abuse or dependence within the past 3 months (participants with episodic abuse related to mood episodes will not be excluded)
boolean
C0038586 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Antisocial Personality Disorder, DSM-IV
Item
satisfies full dsm-iv criteria for antisocial personality disorder, as determined by scid-ii evaluation
boolean
C0003431 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
Suicidal,Therapeutic procedure, inpatient; Psychotic symptom, Therapeutic procedure, inpatient
Item
requires inpatient treatment because of suicidal risk or (current suicidal thinking or parasuicidal behavior is not exclusionary if, in clinician judgment, it can be managed on an outpatient basis)
boolean
C0438696 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0021562 (UMLS CUI [1,3])
C0871189 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0021562 (UMLS CUI [2,3])
ID.15
Item
any of the following medical conditions:
boolean
Depressive episode Due to Prescribed medications
Item
1. an index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.
boolean
C0349217 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3166216 (UMLS CUI [1,3])
Illness (finding), Significant, Uncontrolled, Present
Item
2. presence of significant uncontrolled medical illness including cardiovascular disorder, kidney or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease (stable medical conditions such as well-controlled diabetes or hiv positive status are not exclusionary provided the participant meets other inclusion and exclusion criteria)
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,4])
Depressive disorder, Current Therapy, Pharmacotherapy; Depressive disorder, Current Therapy,Over The Counter Pharmaceutical Preparations; Depressive disorder, Current Therapy, Herbal Drugs; Anxiety, Current Therapy, Pharmacotherapy; Anxiety, Current Therapy, Over The Counter Pharmaceutical Preparations; Anxiety, Current Therapy, Herbal Drugs
Item
3. current treatment with a pharmacologic, over-the-counter, or herbal therapy for depression or anxiety (unless the participant wishes to discontinue an ineffective treatment)
boolean
C0011581 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C2827774 (UMLS CUI [2,2])
C2709201 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
C0011581 (UMLS CUI [3,1])
C2827774 (UMLS CUI [3,2])
C1360419 (UMLS CUI [3,3])
C0003467 (UMLS CUI [4,1])
C2827774 (UMLS CUI [4,2])
C0013216 (UMLS CUI [4,3])
C0003467 (UMLS CUI [5,1])
C2827774 (UMLS CUI [5,2])
C2709201 (UMLS CUI [5,3])
C0013227 (UMLS CUI [5,4])
C0003467 (UMLS CUI [6,1])
C2827774 (UMLS CUI [6,2])
C1360419 (UMLS CUI [6,3])
Poor response to treatment, Citalopram, Previous
Item
history of poor or failed treatment response to an adequate dose and duration of citalopram
boolean
C1320680 (UMLS CUI [1,1])
C0008845 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
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