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OpenTrials
Completed

NCT Number: NCT00561509

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SSRIs

Drug

Use within normal clinical practice

Dual antidepressants

Drug

Use within clinical practice

Primary outcomes

  1. Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2009
First posted
Nov 21, 2007
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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