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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00782964 |
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 |
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Major Depressive Disorder |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Assessment of Therapeutic Strategies in Unipolar Depression With Incomplete Response to a Antidepressant Treatment in Regular Clinical Practicing. |
Estimated Enrollment: | 300 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | July 2009 |
Groups/Cohorts |
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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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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca Pharmaceuticals ( Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager ) |
Study ID Numbers: | NIS-NES-DUM-2007/4 |
Study First Received: | October 30, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00782964 History of Changes |
Health Authority: | Spain: Ethics Committee |
Depression Major Depressive Disorder SSRI resistant depression strategies in depression |
Depression Mental Disorders Psychotropic Drugs Mood Disorders Depressive Disorder, Major |
Depressive Disorder Serotonin Uptake Inhibitors Antidepressive Agents Behavioral Symptoms |
Depression Mental Disorders Therapeutic Uses Psychotropic Drugs Mood Disorders Depressive Disorder, Major |
Depressive Disorder Central Nervous System Agents Pharmacologic Actions Antidepressive Agents Behavioral Symptoms |