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Antidepressant Incomplete Response Depression

NCT ID: NCT00782964

Last Updated: 2009-12-24

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

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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Depression Major Depressive Disorder SSRI resistant depression strategies in depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
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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AstraZeneca Pharmaceuticals

Locations

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Research Site

Albacete, Albacete, Spain

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Alcoy, Alicante, Spain

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Benidorm, Alicante, Spain

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Villajoyosa, Alicante, Spain

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Almería, Almeria, Spain

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Mérida, Badajoz, Spain

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Inca, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, 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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Burgos, Burgos, Spain

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San Fernando, Cadiz, Spain

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Villamartín, 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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Ceuta, Ceuta, Spain

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Córdoba, Cordoba, Spain

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Guadix, Granada, Spain

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Arrasate / Mondragón, 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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Alcalá de Henares, Madrid, Spain

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Alcobendas, Madrid, Spain

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Colmenar Viejo, Madrid, Spain

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Madrid, Madrid, Spain

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Torrejón de Ardoz, Madrid, Spain

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Málaga, Malaga, Spain

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Cartagena, Murcia, Spain

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Pamplona, Navarre, Spain

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Oviedo, Principality of Asturias, Spain

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Salamanca, Salamanca, Spain

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Seville, Sevilla, Spain

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Tarragona, Tarragona, 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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Valencia, Valencia, Spain

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Valladolid, Valladolid, 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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Zaragoza, Zaragoza, Spain

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Barcelona, , Spain

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Countries

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Spain

Other Identifiers

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NIS-NES-DUM-2007/4

Identifier Type: -

Identifier Source: org_study_id