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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01397903

Acronym

MADDRE

Enrollment

545

Registered

2011-07-20

Start date

2011-09-30

Completion date

2012-03-31

Last updated

2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

antidepressant therapy, inadequate control, add-on therapy

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

Greece

Outcome results