Antidepressant Incomplete Response Depression (DRIA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00782964
First received: October 30, 2008
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 364
Study Start Date: October 2008
Study Completion Date: November 2009
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782964

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

No publications provided

Responsible Party: Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00782964     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2007/4
Study First Received: October 30, 2008
Last Updated: December 23, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by AstraZeneca:
Depression
Major Depressive Disorder
SSRI resistant depression
strategies in depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014