ID

28922

Beschrijving

Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01145313

Link

https://clinicaltrials.gov/show/NCT01145313

Trefwoorden

Versies (1)
  1. 16-02-18 16-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT01145313

Engels

Eligibility Depressive Disorder, Major NCT01145313

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet the following criteria will be included in the study:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
aged 18 to 64 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of major depressive disorder during the study timeframe (icd 9 codes 296.2, 296.3, 311)
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
Beschrijving

Antidepressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
Beschrijving

Enrollment Continuous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0549178
evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
Beschrijving

Atypical antipsychotic

Datatype

boolean

Alias
UMLS CUI [1]
C1276996
evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
Beschrijving

Antidepressive Agents prior to Atypical antipsychotic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C1276996
after at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.
Beschrijving

Antidepressive Agents | Atypical antipsychotic Additional

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C1524062
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are excluded if they:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
Beschrijving

Schizophrenia | Schizoaffective Disorder | Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0005586
have electroconvulsive therapy (ect) during the study period
Beschrijving

Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
new augmentation with mood stabilizers, l-thyroxine (t4), l-thyronine (t3), buspirone, stimulant, or others during the post-period (table 1)
Beschrijving

Mood Stabilizer | Thyroxine | Triiodothyronine | Buspirone | Stimulant

Datatype

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0040165
UMLS CUI [3]
C0041014
UMLS CUI [4]
C0006462
UMLS CUI [5]
C0304402
are pregnant during the study period
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patients with medicare or medicaid
Beschrijving

Patients Medicare | Patients Medicaid

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0018717
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0025071
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Similar models

Eligibility Depressive Disorder, Major NCT01145313

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients who meet the following criteria will be included in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
aged 18 to 64 years
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
diagnosis of major depressive disorder during the study timeframe (icd 9 codes 296.2, 296.3, 311)
boolean
C1269683 (UMLS CUI [1])
Antidepressive Agents
Item
evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
boolean
C0003289 (UMLS CUI [1])
Enrollment Continuous
Item
must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
boolean
C1516879 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Atypical antipsychotic
Item
evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
boolean
C1276996 (UMLS CUI [1])
Antidepressive Agents prior to Atypical antipsychotic
Item
evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
boolean
C0003289 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
Antidepressive Agents | Atypical antipsychotic Additional
Item
after at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.
boolean
C0003289 (UMLS CUI [1])
C1276996 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients are excluded if they:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Schizophrenia | Schizoaffective Disorder | Bipolar Disorder
Item
have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
Electroconvulsive Therapy
Item
have electroconvulsive therapy (ect) during the study period
boolean
C0013806 (UMLS CUI [1])
Mood Stabilizer | Thyroxine | Triiodothyronine | Buspirone | Stimulant
Item
new augmentation with mood stabilizers, l-thyroxine (t4), l-thyronine (t3), buspirone, stimulant, or others during the post-period (table 1)
boolean
C2917435 (UMLS CUI [1])
C0040165 (UMLS CUI [2])
C0041014 (UMLS CUI [3])
C0006462 (UMLS CUI [4])
C0304402 (UMLS CUI [5])
Pregnancy
Item
are pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
Patients Medicare | Patients Medicaid
Item
patients with medicare or medicaid
boolean
C0030705 (UMLS CUI [1,1])
C0018717 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0025071 (UMLS CUI [2,2])
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