NCT01397903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

July 18, 2011

Last Update Submit

June 22, 2012

Conditions

Major Depressive Disorder

Keywords

antidepressant therapy, inadequate control, add-on therapy

Outcome Measures

Primary Outcomes (1)

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

    At week 4 after the commencement of add-on therapy

Secondary Outcomes (3)

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

    At week 4 after the commencement of add-on therapy

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

    At week 4 following the onset of add-on medication

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

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

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Psychiatric patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Arta, Artas, Greece

Location

Research Site

Athens, Attica, Greece

Location

Research Site

Chaïdári, Attica, Greece

Location

Research Site

Dafni, Attica, Greece

Location

Research Site

Glyfada, Attica, Greece

Location

Research Site

Kifissia, Attica, Greece

Location

Research Site

Koropí, Attica, Greece

Location

Research Site

Marousi, Attica, Greece

Location

Research Site

Nea Makri, Attica, Greece

Location

Research Site

Peristeri, Attica, Greece

Location

Research Site

Petroúpolis, Attica, Greece

Location

Research Site

Rhodes, Dodekanese, Greece

Location

Research Site

Agrinio, Etoloacarnania, Greece

Location

Research Site

Lamia, Fhiotida, Greece

Location

Research Site

Heraklio, Heraklio, Greece

Location

Research Site

Ioannina, Ioanninon, Greece

Location

Research Site

Kalamata, Kalamata, Greece

Location

Research Site

Karditsa, Karditsa, Greece

Location

Research Site

Kavala, Kavala, Greece

Location

Research Site

Larissa, Larissa, Greece

Location

Research Site

Ag. Nikolaos, Lasithiou, Greece

Location

Research Site

Pátrai, Patras, Greece

Location

Research Site

Aigáleo, Piraeus, Greece

Location

Research Site

Serres, Serres, Greece

Location

Research Site

Thessaloniki, Thessaloniki, Greece

Location

Research Site

Trikala, Trikala, Greece

Location

Research Site

Thebes, Viotia, Greece

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Panagiotis Pontikis

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

GR(27)