ID

17134

Description

Sexual Functioning Study With Antidepressants; ODM derived from: https://clinicaltrials.gov/show/NCT00316160

Link

https://clinicaltrials.gov/show/NCT00316160

Keywords

  1. 8/26/16 8/26/16 -
Uploaded on

August 26, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Depressive Disorder, Major NCT00316160

Eligibility Depressive Disorder, Major NCT00316160

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary diagnosis of major depressive disorder (mdd)
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
must have met dsm-iv criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
Description

Single major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0024517
ham-d17 total score of >17 at screening and baseline.
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
severity of illness score of >4 at screening and baseline.
Description

Severity of illness Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0521117
UMLS CUI [1,2]
C0449820
willing to discuss sexual functioning with investigator or designee.
Description

Sexual functioning Discuss Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0278092
UMLS CUI [1,2]
C2584313
UMLS CUI [1,3]
C0600109
sexual activity that leads to orgasm at least every 2 weeks.
Description

Sexual activity Causing Orgasm Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0029260
UMLS CUI [1,4]
C0376249
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
past or current dsm-iv diagnosis of bipolar disorder i or ii, schizophrenia or another psychotic disorder(s).
Description

Bipolar I disorder | Bipolar II disorder | Schizophrenia | Psychotic Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2]
C0236788
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0033975
primary dsm-iv diagnosis or received treatment for panic disorder, obsessive compulsive disorder or post stress disorder within previous 12 months.
Description

Panic Disorder | Obsessive-Compulsive Disorder | stress related disorder

Data type

boolean

Alias
UMLS CUI [1]
C0030319
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0599909
poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
Description

Risk homicidal | At risk for suicide Serious | Homicide attempt | Suicide attempt | homicidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0745031
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0277662
UMLS CUI [4]
C0038663
UMLS CUI [5]
C0745031
myocardial infarction with 1 year of screening.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
taken ibupropion hydrochloride or venlafaxine in the last 6 months.
Description

Bupropion Hydrochloride | venlafaxine

Data type

boolean

Alias
UMLS CUI [1]
C0700563
UMLS CUI [2]
C0078569
positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
Description

Illicit drug use Urine test Positive | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0038586
psychotherapy within 3 months.
Description

Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
Description

Electroconvulsive Therapy | Transcranial magnetic stimulation

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0436548
ecg or clinical evidence of atrial or ventricular hypertrophy.
Description

Atrial hypertrophy by EKG | Atrial hypertrophy Evidence Clinical | Ventricular hypertrophy on ECG | Ventricular hypertrophy Evidence Clinical

Data type

boolean

Alias
UMLS CUI [1]
C0232311
UMLS CUI [2,1]
C0340278
UMLS CUI [2,2]
C0332120
UMLS CUI [2,3]
C0205210
UMLS CUI [3]
C1856342
UMLS CUI [4,1]
C0340279
UMLS CUI [4,2]
C0332120
UMLS CUI [4,3]
C0205210

Similar models

Eligibility Depressive Disorder, Major NCT00316160

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
primary diagnosis of major depressive disorder (mdd)
boolean
C1269683 (UMLS CUI [1])
Single major depressive episode
Item
must have met dsm-iv criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
boolean
C0024517 (UMLS CUI [1])
Hamilton rating scale for depression
Item
ham-d17 total score of >17 at screening and baseline.
boolean
C0451203 (UMLS CUI [1])
Severity of illness Score
Item
severity of illness score of >4 at screening and baseline.
boolean
C0521117 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Sexual functioning Discuss Willing
Item
willing to discuss sexual functioning with investigator or designee.
boolean
C0278092 (UMLS CUI [1,1])
C2584313 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Sexual activity Causing Orgasm Frequency
Item
sexual activity that leads to orgasm at least every 2 weeks.
boolean
C0036864 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0029260 (UMLS CUI [1,3])
C0376249 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Bipolar I disorder | Bipolar II disorder | Schizophrenia | Psychotic Disorder
Item
past or current dsm-iv diagnosis of bipolar disorder i or ii, schizophrenia or another psychotic disorder(s).
boolean
C0853193 (UMLS CUI [1])
C0236788 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
Panic Disorder | Obsessive-Compulsive Disorder | stress related disorder
Item
primary dsm-iv diagnosis or received treatment for panic disorder, obsessive compulsive disorder or post stress disorder within previous 12 months.
boolean
C0030319 (UMLS CUI [1])
C0028768 (UMLS CUI [2])
C0599909 (UMLS CUI [3])
Risk homicidal | At risk for suicide Serious | Homicide attempt | Suicide attempt | homicidal
Item
poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
boolean
C0035647 (UMLS CUI [1,1])
C0745031 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0277662 (UMLS CUI [3])
C0038663 (UMLS CUI [4])
C0745031 (UMLS CUI [5])
Myocardial Infarction
Item
myocardial infarction with 1 year of screening.
boolean
C0027051 (UMLS CUI [1])
Bupropion Hydrochloride | venlafaxine
Item
taken ibupropion hydrochloride or venlafaxine in the last 6 months.
boolean
C0700563 (UMLS CUI [1])
C0078569 (UMLS CUI [2])
Illicit drug use Urine test Positive | Substance Use Disorders
Item
positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
boolean
C0281875 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2])
Psychotherapy
Item
psychotherapy within 3 months.
boolean
C0033968 (UMLS CUI [1])
Pregnancy
Item
pregnant.
boolean
C0032961 (UMLS CUI [1])
Electroconvulsive Therapy | Transcranial magnetic stimulation
Item
electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
boolean
C0013806 (UMLS CUI [1])
C0436548 (UMLS CUI [2])
Atrial hypertrophy by EKG | Atrial hypertrophy Evidence Clinical | Ventricular hypertrophy on ECG | Ventricular hypertrophy Evidence Clinical
Item
ecg or clinical evidence of atrial or ventricular hypertrophy.
boolean
C0232311 (UMLS CUI [1])
C0340278 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C1856342 (UMLS CUI [3])
C0340279 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])

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