Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response

Study Overview
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Brief Summary
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The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.

Detailed Description
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A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece

Official Title
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A Cross-sectional Observational Study to Describe Treatment Management of Patients With Major Depressive Disorder (MDD) and Inadequate Response to Antidepressants in Greece

Conditions
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Major Depressive Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MDD as per DSM-IV Patients with an inadequate disease control during antidepressant therapy Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study. Exclusion Criteria: Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I, Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Group 1<br>Inpatients and outpatients diagnosed with major depressive disorder as per the DSM-IV criteria who had poor disease control during antidepressant treatment and have completed 4 weeks of add-on drug therapy at enrolment in the study. The percentage of patients with CGI-I score ≤ 2 at study Visit (4 weeks after the commencement of add-on treatment). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2 |  | At week 4 after the commencement of add-on therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication. |  | At week 4 after the commencement of add-on therapy | 
| Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication |  | At week 4 following the onset of add-on medication | 
| Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50% |  | At week 4 following the initiation of add-on drug therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antidepressant therapy, inadequate control, add-on therapy