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
NCT ID: NCT00561509
Last Updated: 2009-07-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
1626 participants
Study Classification
OBSERVATIONAL
Study Start Date
2007-11-30
Study Completion Date
2009-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Major Depressive Disorder
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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A
SSRIs
SSRIs
Intervention Type
DRUG
Use within normal clinical practice
B
Dual antidepressants
Dual antidepressants
Intervention Type
DRUG
Use within clinical practice
Interventions
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SSRIs
Use within normal clinical practice
Intervention Type
DRUG
Dual antidepressants
Use within clinical practice
Intervention Type
DRUG
Eligibility Criteria
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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
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Innsbruck, , Austria
Site Status
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Jenbach, , Austria
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Salzburg, , Austria
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Spital/Drau, , Austria
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Steyr, , Austria
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Vienna, , Austria
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Wels, , Austria
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Wolfsberg, , Austria
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Beijing, , China
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Guangzhou, , China
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Harbin, , China
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Hong Kong, , China
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Jinan, , China
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Shanghai, , China
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Suzhou, , China
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Wuhan, , China
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Pokfulam, , Hong Kong
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Bat Yam, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Herzliya, , Israel
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Hod HaSharon, , Israel
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Ramat Gan, , Israel
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Beirut, , Lebanon
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Kuala Lumpur, , Malaysia
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Cancún, , Mexico
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Guadalajara, , Mexico
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León, , Mexico
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Mexicali, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Puebla City, , Mexico
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San Luis Potosí City, , Mexico
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Tijuana, , Mexico
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Torreón, , Mexico
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Victoria, , Mexico
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Villahermosa, , Mexico
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Lucena City, , Philippines
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Makati, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Dammam, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Khamis Mushait, , Saudi Arabia
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Madinah, , Saudi Arabia
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Mecca, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Hualien City, , Taiwan
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Neihu Taipei, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Abu Dhabi, , United Arab Emirates
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Dubai, , United Arab Emirates
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Countries
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Austria
China
Hong Kong
Israel
Lebanon
Malaysia
Mexico
Philippines
Saudi Arabia
Singapore
Taiwan
Thailand
United Arab Emirates
References
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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.
Reference Type
DERIVED
Other Identifiers
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F1J-MC-B019
Identifier Type: -
Identifier Source: secondary_id
11539
Identifier Type: -
Identifier Source: org_study_id
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