Antidepressant Incomplete Response Depression (DRIA)

December 23, 2009 updated by: AstraZeneca

Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.

Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 3 assessment will be carried out . The 1st one will be on baseline, the 2sd one after a significant change in pharmacological treatment and 3rd one after a second significant change in pharmacological treatment. If there isn´t any significant change in therapeutic plan a control assessment will be carry out in week 10th and 24th. A significant treatment change is defined as a change in SSRI/SNRI, to add another SSRI/SNRI or a augmentation treatment added to SSRI/SNRI. The primary objective is to describe therapeutical strategies (antidepressant change, association with another antidepressant or association with another treatment) in the management of patients with MDD with incomplete response or intolerance to an antidepressant after a first or a second failure; and when the psychiatrist decide a change of strategy. Secondary objectives include: 1 - To describe the clinic profile of depressive patients with incomplete response or intolerance to an antidepressant after a first or a second failure; 2- To describe the profile of patients based on therapeutic strategies used and number of therapeutic strategies; 4- Evaluate the use of health resource due to lack of fast onset of action, and social cost (productivity, care givers…); 5 - To associate clinical variable with therapeutic action by psychiatrist.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain
        • Research Site
      • Almeria, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Ceuta, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Salamanca, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Tarragona, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Alicante
      • Alcoy, Alicante, Spain
        • Research Site
      • Benidorm, Alicante, Spain
        • Research Site
      • Villajoyosa, Alicante, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Badajoz
      • Merida, Badajoz, Spain
        • Research Site
    • Baleares
      • Inca, Baleares, Spain
        • Research Site
      • Palma de Mallorca, Baleares, Spain
        • Research Site
    • Barcelona
      • El Hospitalet de Llobregat, Barcelona, Spain
        • Research Site
      • Martorell, Barcelona, Spain
        • Research Site
      • Vic, Barcelona, Spain
        • Research Site
    • Cadiz
      • San Fernando, Cadiz, Spain
        • Research Site
      • Villamartin, Cadiz, Spain
        • Research Site
    • Cantabria
      • Santander, Cantabria, Spain
        • Research Site
    • Caravaca
      • Murcia, Caravaca, Spain
        • Research Site
    • Castellon
      • Villarreal, Castellon, Spain
        • Research Site
    • Granada
      • Guadix, Granada, Spain
        • Research Site
    • Guipuzcoa
      • Mondragon, Guipuzcoa, Spain
        • Research Site
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain
        • Research Site
    • Lerida
      • Lleida, Lerida, Spain
        • Research Site
    • Madrid
      • Alcala de Henares, Madrid, Spain
        • Research Site
      • Alcobendas, Madrid, Spain
        • Research Site
      • Colmenar Viejo, Madrid, Spain
        • Research Site
      • Torrejon de Ardoz, Madrid, Spain
        • Research Site
    • Murcia
      • Cartagena, Murcia, Spain
        • Research Site
    • Navarra
      • Pamplona, Navarra, Spain
        • Research Site
    • Tarragona
      • Valls, Tarragona, Spain
        • Research Site
    • Tenerife
      • La Cuesta de Arguijon, Tenerife, Spain
        • Research Site
      • Santa Cruz de Tenerife, Tenerife, Spain
        • Research Site
    • Toledo
      • Talavera de La Reina, Toledo, Spain
        • Research Site
    • Valencia
      • Gandia, Valencia, Spain
        • Research Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Research Site
      • Getxo, Vizcaya, Spain
        • Research Site
      • Zalla, Vizcaya, Spain
        • Research Site
    • Zamora
      • Benavente, Zamora, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient with major depressive disorder, who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adecuate dosage of an antidepresant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.

Description

Inclusion Criteria:

  • Provision of written inform consent
  • Diagnosed of Major Depressive Disorder based on DSM-IV-TR
  • Outpatient who has a change in pharmacological therapeutic plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) 5
  • Able to understand and to comply with requirements of the study

Exclusion Criteria:

  • Mental retardation
  • To have been recruited in a clinical trial in the last 4 weeks or to have planned the inclusion in a clinical trial during the follow-up of this study
  • MDD secondary to substance abuse or somatic illness
  • Actual depressive episode with <4 weeks or >12 months of length
  • Current treatment with >1 SSRI/SRNI or previous treatment with >1 SSRI/SRNI, augmentation treatment with SSRI/SRNI, intravenous antidepressant treatment, TMS, ECT or MAO

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Outpatient with major depressive disorder, who has a change in pharmacological therapeutical plan after an incomplete response or intolerance to a treatment with an adequate dosage of an antidepressant (SSRI/NSRI) (20-40 mg fluoxetine, 75-225 mg venlafaxine or equivalent) for at least 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Profile of use of 3 group of strategies: 1 - Change to another antidepressive agent (Quetiapine, Lamotrigine, antidepressant…) 2- Association with another antidepressant 3- Association with any other treatment (antipsychotics, lithium…)
Time Frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical assessment
Time Frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Visits to nurse, psychiatrics: Hospitalization, social support: Productivity assessment
Time Frame: Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).
Baseline, after a significant change in treatment (or control visit after 10th week) and after a 2sd significant change in treatment (or control visit after 24th week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NES-DUM-2007/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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