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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
This study has been completed.
Study NCT00561509   Information provided by Eli Lilly and Company
First Received: November 19, 2007   Last Updated: July 13, 2009   History of Changes

November 19, 2007
July 13, 2009
November 2007
 
Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00561509 on ClinicalTrials.gov Archive Site
  • Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants [ Time Frame: 6 months ]
  • Disease severity [ Time Frame: 6 months ]
  • Resource Utilization [ Time Frame: 6 months ]
  • Quality of Life [ Time Frame: 6 months ]
  • Treatment Compliance [ Time Frame: 6 months ]
  • Identify factors related to sexual dysfunction [ Time Frame: 6 months ]
Same as current
 
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
A Prospective, Observational Study Comparing the Frequency of Treatment-Emergent Sexual Dysfunction Over 8 Weeks in Patients With Major Depressive Disorder Treated With Either Duloxetine Hydrochloride or a Selective Serotonin Reuptake Inhibitor Antidepressant and Evaluated Over 6 Months

In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation. Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their clinical discretion in the benefit of their patients and all clinical decisions will be recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction potentiality.

 
 
Observational
Cohort, Prospective
Major Depressive Disorder
  • Drug: SSRIs
  • Drug: Dual antidepressants
  • SSRIs
  • Dual antidepressants
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1626
June 2009
 

Inclusion Criteria:

  • Meet the criteria for MDD, as defined by the ICD-10 or DSM-IV-TR
  • Are at least moderately depressed (baseline CGI-S less than or equal to 4)
  • Provide written consent to the release of their data after being informed about the study
  • 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
  • Have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity

Exclusion Criteria:

  • 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
  • Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
  • 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
  • Have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
  • Have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   China,   Hong Kong,   Israel,   Lebanon,   Malaysia,   Mexico,   Philippines,   Saudi Arabia,   Singapore,   Taiwan,   Thailand,   United Arab Emirates
 
NCT00561509
 
11539, F1J-MC-B019
Eli Lilly and Company
 
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP