ID

24587

Beskrivning

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon; ODM derived from: https://clinicaltrials.gov/show/NCT00642694

Länk

https://clinicaltrials.gov/show/NCT00642694

Nyckelord

Versioner (1)
  1. 2017-08-08 2017-08-08 -
Uppladdad den

8 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00642694

Engelsk

Eligibility Major Depressive Disorder NCT00642694

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability and willingness to provide written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
primary diagnosis of mdd with initial insomnia.
Beskrivning

Major Depressive Disorder Principal diagnosis | Initial insomnia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332137
UMLS CUI [2]
C0393760
age 18-70.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
screening hrsd17 score greater than or equal to 16 or cgi-s score of at least 4.
Beskrivning

Hamilton Depression Rating Scale 17 Item Questionnaire | CGI - Severity of Illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3639887
subjective report of difficulties with initial insomnia with a score of 2 or greater on the ids-c30 item addressing this symptom (#1). middle and late insomnia may also be present so long as initial insomnia is present.
Beskrivning

Initial insomnia Difficulty with | Questionnaire Symptoms Depressive disorder | Middle insomnia | Late insomnia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0393760
UMLS CUI [1,2]
C0332218
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0683368
UMLS CUI [2,3]
C0011581
UMLS CUI [3]
C0393761
UMLS CUI [4]
C0581874
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of significant comorbid medical condition based on laboratory test, physician information, or evidence at examination; this includes severe sleep apnea, seizure disorder, or chronic obstructive pulmonary disease (copd).
Beskrivning

Comorbidity | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C0037315
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0024117
patient report or evidence (based on physical examination or laboratory tests) of significant medical abnormalities; this includes severe sleep apnea, seizure disorder, or copd.
Beskrivning

Abnormality Physical Examination | Abnormality Laboratory Procedures | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0022885
UMLS CUI [3,1]
C0037315
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0014544
UMLS CUI [5]
C0024117
presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of escitalopram or ramelteon.
Beskrivning

Psychological disorders other | Depressive disorder Due to Comorbidity | At risk for suicide | High suicide risk | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia | Obsessive-Compulsive Disorder | Substance Use Disorders | Mental disorders | Medical contraindication Escitalopram | Medical contraindication ramelteon

Datatyp

boolean

Alias
UMLS CUI [1]
C0497334
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0009488
UMLS CUI [3]
C0563664
UMLS CUI [4]
C1271074
UMLS CUI [5]
C0033975
UMLS CUI [6]
C0853193
UMLS CUI [7]
C0236788
UMLS CUI [8]
C0005586
UMLS CUI [9]
C0036341
UMLS CUI [10]
C0036337
UMLS CUI [11]
C0003123
UMLS CUI [12]
C0006370
UMLS CUI [13]
C0028768
UMLS CUI [14]
C0038586
UMLS CUI [15]
C0004936
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C1099456
UMLS CUI [17,1]
C1301624
UMLS CUI [17,2]
C1565316
concomitant (i.e. within 2 weeks; 4 weeks for fluoxetine or maois) pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, sleep aids including over the counter melatonin, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with ramelteon or escitalopram,, as determined by the study doctor.
Beskrivning

Pharmacotherapy | Fluoxetine | Monoamine Oxidase Inhibitors | Psychotherapy | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizers | Aid to Sleep | Melatonin Over The Counter | Cognitive Therapy | Medical contraindication ramelteon | Medical contraindication Escitalopram

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0033968
UMLS CUI [5]
C0040616
UMLS CUI [6]
C0040615
UMLS CUI [7]
C4020582
UMLS CUI [8]
C0718303
UMLS CUI [9,1]
C0025219
UMLS CUI [9,2]
C2709201
UMLS CUI [10]
C0009244
UMLS CUI [11,1]
C1301624
UMLS CUI [11,2]
C1565316
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C1099456
failure to respond to 2 adequate courses of ssri class antidepressant in the current episode (as measured by the antidepressant treatment history form).
Beskrivning

SSRI Antidepressive Agents | Course Quantity failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0003289
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
hospitalization for mental illness within the past year.
Beskrivning

psychiatric hospitalization

Datatyp

boolean

Alias
UMLS CUI [1]
C0748061
for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding.
Beskrivning

Pregnancy | Pregnancy, Planned | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
patient does not speak english. (patient needs to be fluent in written and oral english because not all assessments are available and/or validated in languages other than english).
Beskrivning

Able to speak English Language Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0332268
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Similar models

Eligibility Major Depressive Disorder NCT00642694

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability and willingness to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder Principal diagnosis | Initial insomnia
Item
primary diagnosis of mdd with initial insomnia.
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0393760 (UMLS CUI [2])
Age
Item
age 18-70.
boolean
C0001779 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire | CGI - Severity of Illness
Item
screening hrsd17 score greater than or equal to 16 or cgi-s score of at least 4.
boolean
C3639712 (UMLS CUI [1])
C3639887 (UMLS CUI [2])
Initial insomnia Difficulty with | Questionnaire Symptoms Depressive disorder | Middle insomnia | Late insomnia
Item
subjective report of difficulties with initial insomnia with a score of 2 or greater on the ids-c30 item addressing this symptom (#1). middle and late insomnia may also be present so long as initial insomnia is present.
boolean
C0393760 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0034394 (UMLS CUI [2,1])
C0683368 (UMLS CUI [2,2])
C0011581 (UMLS CUI [2,3])
C0393761 (UMLS CUI [3])
C0581874 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Comorbidity | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease
Item
presence of significant comorbid medical condition based on laboratory test, physician information, or evidence at examination; this includes severe sleep apnea, seizure disorder, or chronic obstructive pulmonary disease (copd).
boolean
C0009488 (UMLS CUI [1])
C0037315 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0014544 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
Abnormality Physical Examination | Abnormality Laboratory Procedures | Sleep Apnea Severe | Epilepsy | Chronic Obstructive Airway Disease
Item
patient report or evidence (based on physical examination or laboratory tests) of significant medical abnormalities; this includes severe sleep apnea, seizure disorder, or copd.
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C0037315 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0014544 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
Psychological disorders other | Depressive disorder Due to Comorbidity | At risk for suicide | High suicide risk | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia | Obsessive-Compulsive Disorder | Substance Use Disorders | Mental disorders | Medical contraindication Escitalopram | Medical contraindication ramelteon
Item
presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of escitalopram or ramelteon.
boolean
C0497334 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
C0563664 (UMLS CUI [3])
C1271074 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0853193 (UMLS CUI [6])
C0236788 (UMLS CUI [7])
C0005586 (UMLS CUI [8])
C0036341 (UMLS CUI [9])
C0036337 (UMLS CUI [10])
C0003123 (UMLS CUI [11])
C0006370 (UMLS CUI [12])
C0028768 (UMLS CUI [13])
C0038586 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C1301624 (UMLS CUI [16,1])
C1099456 (UMLS CUI [16,2])
C1301624 (UMLS CUI [17,1])
C1565316 (UMLS CUI [17,2])
Pharmacotherapy | Fluoxetine | Monoamine Oxidase Inhibitors | Psychotherapy | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizers | Aid to Sleep | Melatonin Over The Counter | Cognitive Therapy | Medical contraindication ramelteon | Medical contraindication Escitalopram
Item
concomitant (i.e. within 2 weeks; 4 weeks for fluoxetine or maois) pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, sleep aids including over the counter melatonin, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with ramelteon or escitalopram,, as determined by the study doctor.
boolean
C0013216 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C0033968 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
C0040615 (UMLS CUI [6])
C4020582 (UMLS CUI [7])
C0718303 (UMLS CUI [8])
C0025219 (UMLS CUI [9,1])
C2709201 (UMLS CUI [9,2])
C0009244 (UMLS CUI [10])
C1301624 (UMLS CUI [11,1])
C1565316 (UMLS CUI [11,2])
C1301624 (UMLS CUI [12,1])
C1099456 (UMLS CUI [12,2])
SSRI Antidepressive Agents | Course Quantity failed
Item
failure to respond to 2 adequate courses of ssri class antidepressant in the current episode (as measured by the antidepressant treatment history form).
boolean
C0360105 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
psychiatric hospitalization
Item
hospitalization for mental illness within the past year.
boolean
C0748061 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Able to speak English Language Lacking
Item
patient does not speak english. (patient needs to be fluent in written and oral english because not all assessments are available and/or validated in languages other than english).
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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