Antidepressant Incomplete Response Depression
DRIA
Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing.
1 other identifier
observational
364
1 country
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 24, 2009
December 1, 2009
October 30, 2008
December 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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…)
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 Outcomes (2)
Clinical assessment
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
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).
Study Arms (1)
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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Mental retardation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (48)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
October 1, 2008
Study Completion
November 1, 2009
Last Updated
December 24, 2009
Record last verified: 2009-12