Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01397903
First received: July 18, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 545
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1

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).


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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Psychiatric patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397903

Locations
Greece
Research Site
Arta, Artas, Greece
Research Site
Athens, Attika, Greece
Research Site
Chaidari, Attika, Greece
Research Site
Dafni, Attika, Greece
Research Site
Glyfada, Attika, Greece
Research Site
Kifisia, Attika, Greece
Research Site
Koropi, Attika, Greece
Research Site
Maroussi, Attika, Greece
Research Site
Nea Makri, Attika, Greece
Research Site
Peristeri, Attika, Greece
Research Site
Petroupoli, Attika, Greece
Research Site
Rodos, Dodekanese, Greece
Research Site
Agrinio, Etoloacarnania, Greece
Research Site
Lamia, Fhiotida, Greece
Research Site
Ioannina, Ioanninon, Greece
Research Site
Larisa, Larissa, Greece
Research Site
Ag. Nikolaos, Lasithiou, Greece
Research Site
Patra, Patras, Greece
Research Site
Egaleo, Piraeus, Greece
Research Site
Thiva, Viotia, Greece
Research Site
Heraklio, Greece
Research Site
Kalamata, Greece
Research Site
Karditsa, Greece
Research Site
Kavala, Greece
Research Site
Serres, Greece
Research Site
Thessaloniki, Greece
Research Site
Trikala, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Panagiotis Pontikis Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01397903     History of Changes
Other Study ID Numbers: NIS-NGR-XXX-2011/1
Study First Received: July 18, 2011
Last Updated: June 22, 2012
Health Authority: Greece:Hospital's Ethics Committee

Keywords provided by AstraZeneca:
antidepressant therapy, inadequate control, add-on therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014