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

NCT ID: NCT01397903

Last Updated: 2012-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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

Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Panagiotis Pontikis

Role: STUDY_DIRECTOR

Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece

Locations

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Research Site

Arta, Artas, Greece

Site Status

Research Site

Athens, Attica, Greece

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Chaïdári, Attica, Greece

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Dafni, Attica, Greece

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Glyfada, Attica, Greece

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Kifissia, Attica, Greece

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Koropí, Attica, Greece

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Marousi, Attica, Greece

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Nea Makri, Attica, Greece

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Peristeri, Attica, Greece

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Petroúpolis, Attica, Greece

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Rhodes, Dodekanese, Greece

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Agrinio, Etoloacarnania, Greece

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Lamia, Fhiotida, Greece

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Heraklio, Heraklio, Greece

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Ioannina, Ioanninon, Greece

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Kalamata, Kalamata, Greece

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Karditsa, Karditsa, Greece

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Kavala, Kavala, Greece

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Larissa, Larissa, Greece

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Ag. Nikolaos, Lasithiou, Greece

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Pátrai, Patras, Greece

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Aigáleo, Piraeus, Greece

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Serres, Serres, Greece

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Thessaloniki, Thessaloniki, Greece

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Trikala, Trikala, Greece

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Thebes, Viotia, Greece

Site Status

Countries

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Greece

Other Identifiers

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NIS-NGR-XXX-2011/1

Identifier Type: -

Identifier Source: org_study_id

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