ID

17134

Descrição

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

Link

https://clinicaltrials.gov/show/NCT00316160

Palavras-chave

Versões (1)
  1. 26/08/2016 26/08/2016 -
Transferido a

26 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00316160

Inglês

Eligibility Depressive Disorder, Major NCT00316160

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Major Depressive Disorder

Tipo de dados

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.
Descrição

Single major depressive episode

Tipo de dados

boolean

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

Hamilton rating scale for depression

Tipo de dados

boolean

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

Severity of illness Score

Tipo de dados

boolean

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

Sexual functioning Discuss Willing

Tipo de dados

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.
Descrição

Sexual activity Causing Orgasm Frequency

Tipo de dados

boolean

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

Exclusion Criteria

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

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

Tipo de dados

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.
Descrição

Panic Disorder | Obsessive-Compulsive Disorder | stress related disorder

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

Myocardial Infarction

Tipo de dados

boolean

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

Bupropion Hydrochloride | venlafaxine

Tipo de dados

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.
Descrição

Illicit drug use Urine test Positive | Substance Use Disorders

Tipo de dados

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.
Descrição

Psychotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033968
pregnant.
Descrição

Pregnancy

Tipo de dados

boolean

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

Electroconvulsive Therapy | Transcranial magnetic stimulation

Tipo de dados

boolean

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

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

Tipo de dados

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
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Similar models

Eligibility Depressive Disorder, Major NCT00316160

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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