ID

30602

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00930293

Nyckelord

Versioner (1)
  1. 2018-06-17 2018-06-17 -
Rättsinnehavare

see clinical trials.gov

Uppladdad den

17 juni 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Depression NCT00930293

Engelsk

Eligibility Depression NCT00930293

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00930293
Inclusion Criteria
Beskrivning

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)
Beskrivning

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

Datatyp

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
Beskrivning

Panic disorder

Datatyp

boolean

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

Antidepressive Agents, Effectiveness, No

Datatyp

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.
Beskrivning

Suicidal, Outpatient procedure, Effective

Datatyp

boolean

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

Exclusion Criteria

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

Manic episode, Previous; hypomanic episode, Previous

Datatyp

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
Beskrivning

Schizophrenia, Previous; Schizoaffective Disorder, Previous

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Psychotic Disorders, Present

Datatyp

boolean

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

Pregnancy; Pregnancy, Planned

Datatyp

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])
Beskrivning

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

Datatyp

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
Beskrivning

Obsessive-Compulsive Disorder, Severe, primary disorders, Current

Datatyp

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)
Beskrivning

Substance Use Disorders, Previous; Substance Dependence, Previous

Datatyp

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
Beskrivning

Antisocial Personality Disorder, DSM-IV

Datatyp

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)
Beskrivning

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

Datatyp

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:
Beskrivning

ID.15

Datatyp

boolean

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

Depressive episode Due to Prescribed medications

Datatyp

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)
Beskrivning

Illness (finding), Significant, Uncontrolled, Present

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Poor response to treatment, Citalopram, Previous

Datatyp

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 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00930293
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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