Clinical trial NCT01397903: Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: antidepressant therapy, inadequate control, add-on therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric patients

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.

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 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

Primary outcomes:
measure: To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2
timeFrame: At week 4 after the commencement of add-on therapy
Secondary outcomes:
measure: Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.
timeFrame: At week 4 after the commencement of add-on therapy
measure: Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication
timeFrame: At week 4 following the onset of add-on medication
measure: Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%
timeFrame: At week 4 following the initiation of add-on drug therapy.
Other outcomes:
Locations:
city: Arta
country: Greece
facility: Research Site
state: Artas
city: Athens
country: Greece
facility: Research Site
state: Attika
city: Chaidari
country: Greece
facility: Research Site
state: Attika
city: Dafni
country: Greece
facility: Research Site
state: Attika
city: Glyfada
country: Greece
facility: Research Site
state: Attika
city: Kifisia
country: Greece
facility: Research Site
state: Attika
city: Koropi
country: Greece
facility: Research Site
state: Attika
city: Maroussi
country: Greece
facility: Research Site
state: Attika
city: Nea Makri
country: Greece
facility: Research Site
state: Attika
city: Peristeri
country: Greece
facility: Research Site
state: Attika
city: Petroupoli
country: Greece
facility: Research Site
state: Attika
city: Rodos
country: Greece
facility: Research Site
state: Dodekanese
city: Agrinio
country: Greece
facility: Research Site
state: Etoloacarnania
city: Lamia
country: Greece
facility: Research Site
state: Fhiotida
city: Ioannina
country: Greece
facility: Research Site
state: Ioanninon
city: Larisa
country: Greece
facility: Research Site
state: Larissa
city: Ag. Nikolaos
country: Greece
facility: Research Site
state: Lasithiou
city: Patra
country: Greece
facility: Research Site
state: Patras
city: Egaleo
country: Greece
facility: Research Site
state: Piraeus
city: Thiva
country: Greece
facility: Research Site
state: Viotia
city: Heraklio
country: Greece
facility: Research Site
city: Kalamata
country: Greece
facility: Research Site
city: Karditsa
country: Greece
facility: Research Site
city: Kavala
country: Greece
facility: Research Site
city: Serres
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Trikala
country: Greece
facility: Research Site
Study officials:
affiliation: Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
name: Panagiotis Pontikis
role: STUDY_DIRECTOR
References: