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Study 5 of 18 for search of: | United Arab Emirates |
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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00561509 |
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 |
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Major Depressive Disorder |
Drug: SSRIs Drug: Dual antidepressants |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Estimated Enrollment: | 2000 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | July 2009 |
Groups/Cohorts | Assigned Interventions |
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A
SSRIs
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Drug: SSRIs
Use within normal clinical practice
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B
Dual antidepressants
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Drug: Dual antidepressants
Use within clinical practice
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
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 |
Study ID Numbers: | 11539, F1J-MC-B019 |
Study First Received: | November 19, 2007 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00561509 |
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 |
Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Serotonin Duloxetine Behavioral Symptoms |
Pathologic Processes Disease |