Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.
Information provided by:
Eli Lilly and Company Identifier:
First received: November 19, 2007
Last updated: July 13, 2009
Last verified: July 2009

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:

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 ]

Enrollment: 1626
Study Start Date: November 2007
Study Completion Date: June 2009
Groups/Cohorts Assigned Interventions
Drug: SSRIs
Use within normal clinical practice
Dual antidepressants
Drug: Dual antidepressants
Use within clinical practice


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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00561509

  Show 57 Study Locations
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00561509     History of Changes
Other Study ID Numbers: 11539, F1J-MC-B019
Study First Received: November 19, 2007
Last Updated: July 13, 2009
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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Serotonin Uptake Inhibitors
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses processed this record on November 27, 2014