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ID
30478
Description
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
Link
https://clinicaltrials.gov/show/NCT00561509
Keywords
Versions (2)
- 6/7/18 6/7/18 -
- 6/7/18 6/7/18 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
June 7, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Major Depressive Disorder NCT00561509
Eligibility Major Depressive Disorder NCT00561509
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00561509
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
ID.4
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
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])
C0682323 (UMLS CUI [1,2])
C0241028 (UMLS CUI [2,1])
C4060925 (UMLS CUI [2,2])
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])
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])
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])
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])
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
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])
C0332185 (UMLS CUI [1,2])