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NCT Number: NCT01397903

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arta, Artas, Greece

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2

    Time frame: At week 4 after the commencement of add-on therapy

Secondary outcomes

  1. Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.

    Time frame: At week 4 after the commencement of add-on therapy

  2. Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication

    Time frame: At week 4 following the onset of add-on medication

  3. Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%

    Time frame: At week 4 following the initiation of add-on drug therapy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: MADDRE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2011
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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