Study identifier:NIS-NES-DUM-2007/4
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Assessment of therapeutic strategies in unipolar depression with incomplete response to a antidepressant treatment in regular clinical practicing.
Major depressive disorder
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No
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All
364
Observational
18 Years - 65 Years
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Dec 2009 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
ALBACETE, Albacete, Spain
Location
ALCOY, Alicante, Spain
Location
BENIDORM, Alicante, Spain
Location
VILLAJOYOSA, Alicante, Spain
Location
ALMERIA, Almeria, Spain
Location
OVIEDO, ASTURIAS, Spain
Location
MERIDA, Badajoz, Spain
Location
PALMA DE MALLORCA, Baleares, Spain
Arms | Assigned Interventions |
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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. | - |
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