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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561509
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : July 15, 2009
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug: SSRIs Drug: Dual antidepressants

Study Type : Observational
Actual Enrollment : 1626 participants
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
Study Start Date : November 2007
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Group/Cohort Intervention/treatment
Drug: SSRIs
Use within normal clinical practice
Dual antidepressants
Drug: Dual antidepressants
Use within clinical practice

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

Secondary Outcome Measures :
  1. Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants [ Time Frame: 6 months ]
  2. Disease severity [ Time Frame: 6 months ]
  3. Resource Utilization [ Time Frame: 6 months ]
  4. Quality of Life [ Time Frame: 6 months ]
  5. Treatment Compliance [ Time Frame: 6 months ]
  6. Identify factors related to sexual dysfunction [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00561509     History of Changes
Other Study ID Numbers: 11539
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Duloxetine Hydrochloride
Serotonin Uptake Inhibitors
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Agents