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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 is currently recruiting participants.
Study NCT00561509.   Last updated on August 12, 2008.   Information provided by Eli Lilly and Company

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † 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
Official Title † 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
Brief Summary

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.
Detailed Description
Study Phase
Study Type † Observational
Study Design † Cohort, Prospective
Primary Outcome Measure † Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants [ Time Frame: 8 weeks ]
Secondary Outcome Measure † 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 ]
Condition † Major Depressive Disorder
Intervention † Drug: SSRIs
Drug: Dual antidepressants
MEDLINE PMIDs
Links Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 2000
Start Date † November 2007
Completion Date July 2009
Eligibility Criteria †

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)
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559        
Location Countries † Austria,   China,   Hong Kong,   Israel,   Lebanon,   Malaysia,   Mexico,   Philippines,   Saudi Arabia,   Singapore,   Taiwan,   Thailand,   United Arab Emirates
Administrative Information Fields
NCT ID † NCT00561509
Organization ID 11539
Secondary IDs †† F1J-MC-B019
Study Sponsor † Eli Lilly and Company
Collaborators ††
Investigators †
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    
Information Provided By Eli Lilly and Company
Verification Date August 2008
First Received Date † November 19, 2007
Last Updated Date August 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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