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

Major Depressive Disorder Clinical Trial

— MADDRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397903
• Other study ID #: NIS-NGR-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: June 22, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece:Hospital's Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
Greece	Research Site	Ag. Nikolaos	Lasithiou
Greece	Research Site	Agrinio	Etoloacarnania
Greece	Research Site	Arta	Artas
Greece	Research Site	Athens	Attika
Greece	Research Site	Chaidari	Attika
Greece	Research Site	Dafni	Attika
Greece	Research Site	Egaleo	Piraeus
Greece	Research Site	Glyfada	Attika
Greece	Research Site	Heraklio
Greece	Research Site	Ioannina	Ioanninon
Greece	Research Site	Kalamata
Greece	Research Site	Karditsa
Greece	Research Site	Kavala
Greece	Research Site	Kifisia	Attika
Greece	Research Site	Koropi	Attika
Greece	Research Site	Lamia	Fhiotida
Greece	Research Site	Larisa	Larissa
Greece	Research Site	Maroussi	Attika
Greece	Research Site	Nea Makri	Attika
Greece	Research Site	Patra	Patras
Greece	Research Site	Peristeri	Attika
Greece	Research Site	Petroupoli	Attika
Greece	Research Site	Rodos	Dodekanese
Greece	Research Site	Serres
Greece	Research Site	Thessaloniki
Greece	Research Site	Thiva	Viotia
Greece	Research Site	Trikala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage of patients (n,%) with a change (decrease) in MADRS score be = 50%		At week 4 following the initiation of add-on drug therapy.	No