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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.
Verified by Eli Lilly and Company, August 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00561509
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Drug: SSRIs
Drug: Dual antidepressants

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Serotonin Duloxetine Duloxetine hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 2000
Study Start Date: November 2007
Estimated Study Completion Date: July 2009
Groups/Cohorts Assigned Interventions
A
SSRIs
Drug: SSRIs
Use within normal clinical practice
B
Dual antidepressants
Drug: Dual antidepressants
Use within clinical practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population will consist of sexually active male and female patients, 18 years or older with a primary diagnosis of MDD, for whom the treating clinician makes a decision to treat with a SSRI or SNRI antidepressant. Eligible patients must agree to participate in the collection of data, and must not present with treatment resistant depression or have sexual dysfunction at study entry.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561509

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 60 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Study ID Numbers: 11539, F1J-MC-B019
Study First Received: November 19, 2007
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00561509  
Health Authority: Korea: Food and Drug Administration;   China: Ethics Committee;   Philippines: Department of Health;   Mexico: Ethics Committee;   Taiwan: Institutional Review Board;   Hong Kong: Department of Health;   Singapore: Domain Specific Review Boards;   Israel: The Israel National Institute for Health Policy Research and Health Services Research;   Lebanon: Institutional Review Board;   Saudi Arabia: Research Advisory Council;   United Arab Emirates: General Authority for Health Services for Abu Dhabi;   Austria: Ethikkommission;   Malaysia: Ministry of Health;   Thailand: Ethical Committee

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009