NCT00561509

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Geographic Reach
13 countries

57 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

First QC Date

November 19, 2007

Last Update Submit

July 13, 2009

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (6)

  • Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants

    6 months

  • Disease severity

    6 months

  • Resource Utilization

    6 months

  • Quality of Life

    6 months

  • Treatment Compliance

    6 months

  • +1 more secondary outcomes

Study Arms (2)

A

SSRIs

Drug: SSRIs

B

Dual antidepressants

Drug: Dual antidepressants

Interventions

SSRIsDRUG

Use within normal clinical practice

A
Dual antidepressantsDRUG

Use within clinical practice

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

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Innsbruck, Austria

Location

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Jenbach, Austria

Location

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Salzburg, Austria

Location

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Spital/Drau, Austria

Location

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Steyr, Austria

Location

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Vienna, Austria

Location

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Wels, Austria

Location

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Wolfsberg, Austria

Location

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Beijing, China

Location

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Guangzhou, China

Location

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Harbin, China

Location

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Hong Kong, China

Location

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Jinan, China

Location

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Shanghai, China

Location

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Suzhou, China

Location

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Wuhan, China

Location

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Pokfulam, Hong Kong

Location

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Bat Yam, Israel

Location

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Beersheba, Israel

Location

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Haifa, Israel

Location

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Herzliya, Israel

Location

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Hod HaSharon, Israel

Location

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Ramat Gan, Israel

Location

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Beirut, Lebanon

Location

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Kuala Lumpur, Malaysia

Location

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Cancún, Mexico

Location

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Guadalajara, Mexico

Location

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León, Mexico

Location

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Mexicali, Mexico

Location

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Mexico City, Mexico

Location

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Mérida, Mexico

Location

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Monterrey, Mexico

Location

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Morelia, Mexico

Location

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Puebla City, Mexico

Location

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San Luis Potosí City, Mexico

Location

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Tijuana, Mexico

Location

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Torreón, Mexico

Location

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Victoria, Mexico

Location

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Villahermosa, Mexico

Location

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Lucena City, Philippines

Location

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Makati, Philippines

Location

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Pasig, Philippines

Location

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Quezon City, Philippines

Location

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Dammam, Saudi Arabia

Location

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Jeddah, Saudi Arabia

Location

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Khamis Mushait, Saudi Arabia

Location

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Madinah, Saudi Arabia

Location

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Mecca, Saudi Arabia

Location

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Riyadh, Saudi Arabia

Location

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Singapore, Singapore

Location

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Hualien City, Taiwan

Location

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Neihu Taipei, Taiwan

Location

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Taichung, Taiwan

Location

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Taipei, Taiwan

Location

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Bangkok, Thailand

Location

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Abu Dhabi, United Arab Emirates

Location

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Dubai, United Arab Emirates

Location

Related Publications (1)

  • Duenas H, Lara C, Walton RJ, Granger RE, Dossenbach M, Raskin J. The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder. Int J Psychiatry Clin Pract. 2011 Sep;15(3):171-9. doi: 10.3109/13651501.2011.555820. Epub 2011 Feb 8.

    PMID: 22121927DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 21, 2007

Study Start

November 1, 2007

Study Completion

June 1, 2009

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

TH(1)PH(4)MY(1)SA(6)SG(1)TW(4)AU(8)IL(6)LE(1)AE(2)CN(8)ME(14)HK(1)