Major Depressive Disorder
Conditions
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.
Interventions
DRUGSSRIs
Use within normal clinical practice
DRUGDual antidepressants
Use within clinical practice
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Disease severity | 6 months |
| Resource Utilization | 6 months |
| Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants | 6 months |
| Treatment Compliance | 6 months |
| Identify factors related to sexual dysfunction | 6 months |
| Quality of Life | 6 months |
Countries
Austria, China, Hong Kong, Israel, Lebanon, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates
Outcome results
None listed