ID

30479

Beskrivning

Multi-Country Observational Study to Collect the Frequency of Sexual Dysfunction With Antidepressant Treatment, Either With SSRIs or Duals at 8 Weeks and 6 Months; ODM derived from: https://clinicaltrials.gov/show/NCT00561509

Länk

https://clinicaltrials.gov/show/NCT00561509

Nyckelord

Versioner (2)
  1. 2018-06-07 2018-06-07 -
  2. 2018-06-07 2018-06-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00561509

Engelsk

Eligibility Major Depressive Disorder NCT00561509

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet the criteria for mdd, as defined by the icd-10 or dsm-iv-tr
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
are at least moderately depressed (baseline cgi-s less than or equal to 4)
Beskrivning

Moderate depression CGI - Severity of Illness | Severe depression CGI - Severity of Illness

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0588007
UMLS CUI [1,2]
C3639887
UMLS CUI [2,1]
C0588008
UMLS CUI [2,2]
C3639887
provide written consent to the release of their data after being informed about the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
present with an episode of mdd (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available ssri or snri class of antidepressant in accordance with the investigator's decision for the management of the patient
Beskrivning

Major depressive episode | Major depressive episode New | Major depressife episode First | Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C0024517
UMLS CUI [3,2]
C0205435
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0360105
UMLS CUI [6]
C1579361
have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
Beskrivning

Sexually active Partner | Sexually active Engagement in autoerotic sexual acts

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0682323
UMLS CUI [2,1]
C0241028
UMLS CUI [2,2]
C4060925
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
meet any of the following criteria for sexual dysfunction at study entry (mcgahuey et all. 2000: asex total score less than or equal 19 or asex score less than or equal to 5 on any item, or asex score less than or equal to 4 on any 3 items
Beskrivning

Sexual Dysfunction | Arizona Sexual Experiences Scale-Male Version Questionnaire | Arizona Sexual Experiences Scale-Female Version Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C0549622
UMLS CUI [2]
C4289960
UMLS CUI [3]
C4289961
are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
Beskrivning

Study Subject Participation Status | Interventional procedure | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0013230
have a history of treatment resistant depression (trd) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
Beskrivning

Depressive Disorder, Treatment-Resistant | Antidepressive Agents Class Different Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [2,4]
C1265611
have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
Beskrivning

Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Dysthymic Disorder | Mental Retardation | Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0013415
UMLS CUI [6]
C0025362
UMLS CUI [7]
C0497327
have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
Beskrivning

Antidepressive Agents Recently | Fluoxetine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C0016365
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Similar models

Eligibility Major Depressive Disorder NCT00561509

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
meet the criteria for mdd, as defined by the icd-10 or dsm-iv-tr
boolean
C1269683 (UMLS CUI [1])
Moderate depression CGI - Severity of Illness | Severe depression CGI - Severity of Illness
Item
are at least moderately depressed (baseline cgi-s less than or equal to 4)
boolean
C0588007 (UMLS CUI [1,1])
C3639887 (UMLS CUI [1,2])
C0588008 (UMLS CUI [2,1])
C3639887 (UMLS CUI [2,2])
Informed Consent
Item
provide written consent to the release of their data after being informed about the study
boolean
C0021430 (UMLS CUI [1])
Major depressive episode | Major depressive episode New | Major depressife episode First | Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
Item
present with an episode of mdd (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available ssri or snri class of antidepressant in accordance with the investigator's decision for the management of the patient
boolean
C0024517 (UMLS CUI [1])
C0024517 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0024517 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4])
C0360105 (UMLS CUI [5])
C1579361 (UMLS CUI [6])
Sexually active Partner | Sexually active Engagement in autoerotic sexual acts
Item
have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity
boolean
C0241028 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C0241028 (UMLS CUI [2,1])
C4060925 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Sexual Dysfunction | Arizona Sexual Experiences Scale-Male Version Questionnaire | Arizona Sexual Experiences Scale-Female Version Questionnaire
Item
meet any of the following criteria for sexual dysfunction at study entry (mcgahuey et all. 2000: asex total score less than or equal 19 or asex score less than or equal to 5 on any item, or asex score less than or equal to 4 on any 3 items
boolean
C0549622 (UMLS CUI [1])
C4289960 (UMLS CUI [2])
C4289961 (UMLS CUI [3])
Study Subject Participation Status | Interventional procedure | Investigational New Drugs
Item
are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Depressive Disorder, Treatment-Resistant | Antidepressive Agents Class Different Quantity
Item
have a history of treatment resistant depression (trd) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
boolean
C2063866 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Dysthymic Disorder | Mental Retardation | Dementia
Item
have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0013415 (UMLS CUI [5])
C0025362 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
Antidepressive Agents Recently | Fluoxetine
Item
have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
boolean
C0003289 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2])
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