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

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01397903
• Lead Sponsor: AstraZeneca

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Study Start: 2011-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Research Site; 🇬🇷 Trikala, Greece