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

Study Overview
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: SSRIs
* Drug: Dual antidepressants


Participation Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>SSRIs | Drug: SSRIs<br>* Use within normal clinical practice<br>|
| B<br>Dual antidepressants | Drug: Dual antidepressants<br>* Use within clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Identify factors related to sexual dysfunction |  | 6 months |