ID

36347

Beskrivning

Microbiome of Depression & Treatment Response to Citalopram; ODM derived from: https://clinicaltrials.gov/show/NCT02330068

Länk

https://clinicaltrials.gov/show/NCT02330068

Nyckelord

Versioner (1)
  1. 2019-05-05 2019-05-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02330068

Engelsk

Eligibility Major Depressive Disorder NCT02330068

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients or inpatients with nonpsychotic major depressive disorder (mdd).
Beskrivning

Outpatients | Inpatients | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0021562
UMLS CUI [3]
C0743081
a score of >16 on the qids
Beskrivning

QIDS

Datatyp

boolean

Alias
UMLS CUI [1]
C4300148
outpatients or inpatients for whom antidepressant treatment is deemed appropriate by the treating clinician
Beskrivning

Antidepressant therapy Appropriate Outpatients | Antidepressant therapy Appropriate Inpatients

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0029921
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0021562
subjects who are between 18-55 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to citalopram treatment
Beskrivning

Medical contraindication Citalopram

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0008845
axis i or ii disorder other than depression that is the primary reason for seeking treatment intervention and/or psychiatric care
Beskrivning

Axis I diagnosis | Axis II diagnosis | Exception Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C0270288
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011581
for healthy controls, a first degree relative who has been diagnosed with an axis i disorder
Beskrivning

Healthy Control | First Degree Relative Axis I diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0270287
patients with schizophrenia, schizoaffective disorder, or bipolar i disorder
Beskrivning

Schizophrenia | Schizoaffective Disorder | Bipolar I disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0853193
antidepressant treatment within 4 days of study (1 week if fluoxetine). subjects currently on antidepressant medication with subtherapeutic results in terms of depression management after providing informed consent, will undergo a medication taper and discontinuation prior to initiation of citalopram treatment. the subject must be off of previous antidepressants for at least 4 days week prior to starting citalopram (1 week if fluoxetine). the subject will be closely monitored by the research study psychiatrist (with or without additional monitoring from primary clinical psychiatric providers). the medication taper is left up to the research study psychiatrist in consultation with patient's primary care or psychiatric provider. study subjects who cannot be safely tapered from their medication or experience adverse effects during the taper will be excluded from the study
Beskrivning

Antidepressant therapy | Fluoxetine | Antidepressive Agents To be stopped | Status pre- Initiation Citalopram

Datatyp

boolean

Alias
UMLS CUI [1]
C1096649
UMLS CUI [2]
C0016365
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C1272691
UMLS CUI [4,1]
C0332152
UMLS CUI [4,2]
C1704686
UMLS CUI [4,3]
C0008845
study subjects using their antidepressant medication for management of nicotine dependence, chronic pain, migraine prophylaxis, or other diagnoses will not be eligible for the study
Beskrivning

Antidepressive Agents Management Nicotine Dependence | Antidepressive Agents Management Chronic pain | Antidepressive Agents Migraine prophylaxis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0376636
UMLS CUI [1,3]
C0028043
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0376636
UMLS CUI [2,3]
C0150055
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C1142085
subjects currently on antipsychotic medications (i.e., typical or atypical antipsychotic drugs) and mood stabilizing(e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) are not eligible for the study. trazodone, melatonin, and diphenhydramine may be used as rescue medications for insomnia. benzodiazepines may be used for treatment of anxiety, not to exceed 4 mg/24 hour of lorazepam
Beskrivning

Antipsychotic Agents | Typical Antipsychotic | Atypical antipsychotic | Mood stabilizing drug | Lithium | Carbamazepine | Valproate | lamotrigine | gabapentin | Anticonvulsants | Allowed Trazodone Sleeplessness | Allowed Melatonin Sleeplessness | Allowed Diphenhydramine Sleeplessness | Allowed Benzodiazepines Anxiety | Allowed Lorazepam Anxiety

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C2917392
UMLS CUI [3]
C1276996
UMLS CUI [4]
C1276998
UMLS CUI [5]
C0023870
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0080356
UMLS CUI [8]
C0064636
UMLS CUI [9]
C0060926
UMLS CUI [10]
C0003286
UMLS CUI [11,1]
C0683607
UMLS CUI [11,2]
C0040805
UMLS CUI [11,3]
C0917801
UMLS CUI [12,1]
C0683607
UMLS CUI [12,2]
C0025219
UMLS CUI [12,3]
C0917801
UMLS CUI [13,1]
C0683607
UMLS CUI [13,2]
C0012522
UMLS CUI [13,3]
C0917801
UMLS CUI [14,1]
C0683607
UMLS CUI [14,2]
C0005064
UMLS CUI [14,3]
C0003467
UMLS CUI [15,1]
C0683607
UMLS CUI [15,2]
C0024002
UMLS CUI [15,3]
C0003467
subjects who are currently on an antibiotic or an antibiotic within 2 weeks. (topical antibiotics are ok)
Beskrivning

Antibiotics | ANTIBIOTICS FOR TOPICAL USE allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2,1]
C3653723
UMLS CUI [2,2]
C0683607
daily use of aspirin, nsaid's or warfarin (low dose of baby aspirin ok)
Beskrivning

Aspirin Daily | NSAIDs Daily | Warfarin Daily | Aspirin Low Dose allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0332173
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0332173
UMLS CUI [3,1]
C0043031
UMLS CUI [3,2]
C0332173
UMLS CUI [4,1]
C2608320
UMLS CUI [4,2]
C0683607
subjects unable to give informed consent are excluded
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
pregnant subjects will be excluded
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
subjects who are currently breastfeeding and who plan to continue breastfeeding will be excluded
Beskrivning

Breast Feeding | Breast Feeding Continue Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0549178
UMLS CUI [2,3]
C1301732
postmenopausal women are not eligible for this study
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
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Similar models

Eligibility Major Depressive Disorder NCT02330068

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Inpatients | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
outpatients or inpatients with nonpsychotic major depressive disorder (mdd).
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
C0743081 (UMLS CUI [3])
QIDS
Item
a score of >16 on the qids
boolean
C4300148 (UMLS CUI [1])
Antidepressant therapy Appropriate Outpatients | Antidepressant therapy Appropriate Inpatients
Item
outpatients or inpatients for whom antidepressant treatment is deemed appropriate by the treating clinician
boolean
C1096649 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
C1096649 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0021562 (UMLS CUI [2,3])
Age
Item
subjects who are between 18-55 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Citalopram
Item
contraindications to citalopram treatment
boolean
C1301624 (UMLS CUI [1,1])
C0008845 (UMLS CUI [1,2])
Axis I diagnosis | Axis II diagnosis | Exception Depressive disorder
Item
axis i or ii disorder other than depression that is the primary reason for seeking treatment intervention and/or psychiatric care
boolean
C0270287 (UMLS CUI [1])
C0270288 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011581 (UMLS CUI [3,2])
Healthy Control | First Degree Relative Axis I diagnosis
Item
for healthy controls, a first degree relative who has been diagnosed with an axis i disorder
boolean
C2986479 (UMLS CUI [1])
C1517194 (UMLS CUI [2,1])
C0270287 (UMLS CUI [2,2])
Schizophrenia | Schizoaffective Disorder | Bipolar I disorder
Item
patients with schizophrenia, schizoaffective disorder, or bipolar i disorder
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
Antidepressant therapy | Fluoxetine | Antidepressive Agents To be stopped | Status pre- Initiation Citalopram
Item
antidepressant treatment within 4 days of study (1 week if fluoxetine). subjects currently on antidepressant medication with subtherapeutic results in terms of depression management after providing informed consent, will undergo a medication taper and discontinuation prior to initiation of citalopram treatment. the subject must be off of previous antidepressants for at least 4 days week prior to starting citalopram (1 week if fluoxetine). the subject will be closely monitored by the research study psychiatrist (with or without additional monitoring from primary clinical psychiatric providers). the medication taper is left up to the research study psychiatrist in consultation with patient's primary care or psychiatric provider. study subjects who cannot be safely tapered from their medication or experience adverse effects during the taper will be excluded from the study
boolean
C1096649 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0003289 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0332152 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
C0008845 (UMLS CUI [4,3])
Antidepressive Agents Management Nicotine Dependence | Antidepressive Agents Management Chronic pain | Antidepressive Agents Migraine prophylaxis
Item
study subjects using their antidepressant medication for management of nicotine dependence, chronic pain, migraine prophylaxis, or other diagnoses will not be eligible for the study
boolean
C0003289 (UMLS CUI [1,1])
C0376636 (UMLS CUI [1,2])
C0028043 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C0376636 (UMLS CUI [2,2])
C0150055 (UMLS CUI [2,3])
C0003289 (UMLS CUI [3,1])
C1142085 (UMLS CUI [3,2])
Antipsychotic Agents | Typical Antipsychotic | Atypical antipsychotic | Mood stabilizing drug | Lithium | Carbamazepine | Valproate | lamotrigine | gabapentin | Anticonvulsants | Allowed Trazodone Sleeplessness | Allowed Melatonin Sleeplessness | Allowed Diphenhydramine Sleeplessness | Allowed Benzodiazepines Anxiety | Allowed Lorazepam Anxiety
Item
subjects currently on antipsychotic medications (i.e., typical or atypical antipsychotic drugs) and mood stabilizing(e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) are not eligible for the study. trazodone, melatonin, and diphenhydramine may be used as rescue medications for insomnia. benzodiazepines may be used for treatment of anxiety, not to exceed 4 mg/24 hour of lorazepam
boolean
C0040615 (UMLS CUI [1])
C2917392 (UMLS CUI [2])
C1276996 (UMLS CUI [3])
C1276998 (UMLS CUI [4])
C0023870 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0080356 (UMLS CUI [7])
C0064636 (UMLS CUI [8])
C0060926 (UMLS CUI [9])
C0003286 (UMLS CUI [10])
C0683607 (UMLS CUI [11,1])
C0040805 (UMLS CUI [11,2])
C0917801 (UMLS CUI [11,3])
C0683607 (UMLS CUI [12,1])
C0025219 (UMLS CUI [12,2])
C0917801 (UMLS CUI [12,3])
C0683607 (UMLS CUI [13,1])
C0012522 (UMLS CUI [13,2])
C0917801 (UMLS CUI [13,3])
C0683607 (UMLS CUI [14,1])
C0005064 (UMLS CUI [14,2])
C0003467 (UMLS CUI [14,3])
C0683607 (UMLS CUI [15,1])
C0024002 (UMLS CUI [15,2])
C0003467 (UMLS CUI [15,3])
Antibiotics | ANTIBIOTICS FOR TOPICAL USE allowed
Item
subjects who are currently on an antibiotic or an antibiotic within 2 weeks. (topical antibiotics are ok)
boolean
C0003232 (UMLS CUI [1])
C3653723 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Aspirin Daily | NSAIDs Daily | Warfarin Daily | Aspirin Low Dose allowed
Item
daily use of aspirin, nsaid's or warfarin (low dose of baby aspirin ok)
boolean
C0004057 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0043031 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C2608320 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Informed Consent Unable
Item
subjects unable to give informed consent are excluded
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
pregnant subjects will be excluded
boolean
C0032961 (UMLS CUI [1])
Breast Feeding | Breast Feeding Continue Planned
Item
subjects who are currently breastfeeding and who plan to continue breastfeeding will be excluded
boolean
C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Postmenopausal state
Item
postmenopausal women are not eligible for this study
boolean
C0232970 (UMLS CUI [1])
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