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Trial record 6 of 9 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Greece )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397903
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Major Depressive Disorder

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

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Study Type : Observational
Actual Enrollment : 545 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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).

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Psychiatric patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397903

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

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Responsible Party: AstraZeneca Identifier: NCT01397903     History of Changes
Other Study ID Numbers: NIS-NGR-XXX-2011/1
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012
Keywords provided by AstraZeneca:
antidepressant therapy, inadequate control, add-on therapy
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs