ID

19453

Description

Risperidone vs. Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00179244

Link

https://clinicaltrials.gov/show/NCT00179244

Keywords

Versions (1)
  1. 1/3/17 1/3/17 -
Uploaded on

January 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Unipolar Depression NCT00179244

English

Eligibility Unipolar Depression NCT00179244

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Moderate | Severe major depression without psychotic features

Data type

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0205081
UMLS CUI [2]
C0270457
ham-d 17 score of 18 or above
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
have a documentable history of 2 prior adequate trials of antidepressants including an ssri without sufficient response. a clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
Description

Antidepressive Agents Trials Quantity | Selective Serotonin Reuptake Inhibitors | Depressive Symptoms Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0360105
UMLS CUI [3,1]
C0086132
UMLS CUI [3,2]
C0438286
must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
Description

Serotonin Uptake Inhibitor Dose Adequate | venlafaxine | duloxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C0162758
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0078569
UMLS CUI [3]
C0245561
ability and willingness to provide consent for participation in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any medical condition that would preclude treatment with an ssri, risperidone, or bupropion er
Description

Medical condition Excludes Selective Serotonin Reuptake Inhibitors | Medical condition Excludes Risperidone | Medical condition Excludes Bupropion Extended Release

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0360105
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0073393
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1252646
any clinically significant unstable medical condition
Description

Medical condition Unstable Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C2826293
diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
Description

Bipolar Disorder | Psychotic Disorder Primary

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0205225
current psychotic symptoms (hallucination or delusions)
Description

Psychotic symptom | Hallucinations | Delusions

Data type

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C0018524
UMLS CUI [3]
C0011253
alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
Description

Substance Use Disorders | Substance Dependence | Nicotine Dependence | Nicotine abuse | Caffeine dependence | Caffeine abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0028043
UMLS CUI [4]
C2363943
UMLS CUI [5]
C1386553
UMLS CUI [6]
C0679260
documented non-response to the combination of a novel antipsychotic or bupropion er and a ssri
Description

Antipsychotic Agent New | Bupropion Extended Release | Selective Serotonin Reuptake Inhibitors | Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205314
UMLS CUI [2]
C1252646
UMLS CUI [3]
C0360105
UMLS CUI [4]
C0438286
concomitant use of any psychotropic other than an ssri or zolpidem (prn for sleep)
Description

Psychotropic Drugs | Selective Serotonin Reuptake Inhibitors | zolpidem

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0360105
UMLS CUI [3]
C0078839
score of 4 on the suicide item of the ham-d scale and determination by the investigator of significant suicide risk
Description

Hamilton rating scale for depression | At risk for suicide Significant

Data type

boolean

Alias
UMLS CUI [1]
C0451203
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0750502
known sensitivity to risperidone or bupropion er
Description

Hypersensitivity Risperidone | Hypersensitivity Bupropion Extended Release

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1252646
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Similar models

Eligibility Unipolar Depression NCT00179244

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female 18 years or older
boolean
C0001779 (UMLS CUI [1])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Moderate | Severe major depression without psychotic features
Item
dsm-iv diagnosis of major depressive disorder of at least moderate severity, but without psychotic features
boolean
C0743081 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0270457 (UMLS CUI [2])
Hamilton rating scale for depression
Item
ham-d 17 score of 18 or above
boolean
C0451203 (UMLS CUI [1])
Antidepressive Agents Trials Quantity | Selective Serotonin Reuptake Inhibitors | Depressive Symptoms Absent response to treatment
Item
have a documentable history of 2 prior adequate trials of antidepressants including an ssri without sufficient response. a clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms.
boolean
C0003289 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0360105 (UMLS CUI [2])
C0086132 (UMLS CUI [3,1])
C0438286 (UMLS CUI [3,2])
Serotonin Uptake Inhibitor Dose Adequate | venlafaxine | duloxetine
Item
must be currently on an serotonin uptake inhibitor (to include venlafaxine or duloxetine) at an adequate dose for at least 3 weeks.
boolean
C0162758 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0078569 (UMLS CUI [2])
C0245561 (UMLS CUI [3])
Informed Consent
Item
ability and willingness to provide consent for participation in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Excludes Selective Serotonin Reuptake Inhibitors | Medical condition Excludes Risperidone | Medical condition Excludes Bupropion Extended Release
Item
any medical condition that would preclude treatment with an ssri, risperidone, or bupropion er
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0360105 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0073393 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1252646 (UMLS CUI [3,3])
Medical condition Unstable Clinical Significance
Item
any clinically significant unstable medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Bipolar Disorder | Psychotic Disorder Primary
Item
diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Psychotic symptom | Hallucinations | Delusions
Item
current psychotic symptoms (hallucination or delusions)
boolean
C0871189 (UMLS CUI [1])
C0018524 (UMLS CUI [2])
C0011253 (UMLS CUI [3])
Substance Use Disorders | Substance Dependence | Nicotine Dependence | Nicotine abuse | Caffeine dependence | Caffeine abuse
Item
alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0028043 (UMLS CUI [3])
C2363943 (UMLS CUI [4])
C1386553 (UMLS CUI [5])
C0679260 (UMLS CUI [6])
Antipsychotic Agent New | Bupropion Extended Release | Selective Serotonin Reuptake Inhibitors | Absent response to treatment
Item
documented non-response to the combination of a novel antipsychotic or bupropion er and a ssri
boolean
C0040615 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1252646 (UMLS CUI [2])
C0360105 (UMLS CUI [3])
C0438286 (UMLS CUI [4])
Psychotropic Drugs | Selective Serotonin Reuptake Inhibitors | zolpidem
Item
concomitant use of any psychotropic other than an ssri or zolpidem (prn for sleep)
boolean
C0033978 (UMLS CUI [1])
C0360105 (UMLS CUI [2])
C0078839 (UMLS CUI [3])
Hamilton rating scale for depression | At risk for suicide Significant
Item
score of 4 on the suicide item of the ham-d scale and determination by the investigator of significant suicide risk
boolean
C0451203 (UMLS CUI [1])
C0563664 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Hypersensitivity Risperidone | Hypersensitivity Bupropion Extended Release
Item
known sensitivity to risperidone or bupropion er
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1252646 (UMLS CUI [2,2])
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