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Mirtazapine naturalistic depression study (in Sweden) - MINDS(S): Clinical efficacy and safety
Linköping University, Faculty of Health Sciences. Linköping University, Department of Neuroscience and Locomotion, Psychiatry. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Psychiatry.
Linköping University, Faculty of Health Sciences. Linköping University, Department of Neuroscience and Locomotion, Psychiatry. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Psychiatry.
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2006 (English)In: Human Psychopharmacology: Clinical and Experimental, ISSN 0885-6222, E-ISSN 1099-1077, Vol. 21, no 3, 151-158 p.Article in journal (Refereed) Published
Abstract [en]

Objective: To study how implementation of a naturalistic trial design for mirtazapine treatment in major depressive disorder for six (up to 12) months could be used and evaluated by means of clinical efficacy and safety. Method: An open-labelled, prospective, multicenter, non-comparative trial was conducted during a 2-year period in patients with major depression according to DSM-IV treated in psychiatric departments and primary care in Sweden. Minimal inclusion and exclusion criteria were used in order to diminish the potential patient selection bias. Maximum flexibility of the dosage of mirtazapine was allowed, and clinical assessments included MADRS, CGI, vital signs and spontaneous reporting of adverse events. Results: 192 patients were found eligible and enrolled in the study. A significant improvement in depressive symptoms according to MADRS and CGI was observed including particularly marked sleep improvement early in the treatment. Slight increases in body weight and BMI were observed. The investigational drug was well tolerated overall. Conclusion: The clinical efficacy and safety of mirtazapine found in this naturalistic setting is in line with previously reported data on mirtazapine in traditional controlled clinical trials. The results confirm that the naturalistic study design facilitated conduct of the trial. The authors suggest that this type of study design should also be applied to other antidepressant drugs that are frequently prescribed in the general population. Copyright © 2006 John Wiley & Sons, Ltd.

Place, publisher, year, edition, pages
2006. Vol. 21, no 3, 151-158 p.
Keyword [en]
mirtazapine, selection bias, naturalistic study design, major depression
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Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-33834DOI: 10.1002/hup.753Local ID: 19904OAI: oai:DiVA.org:liu-33834DiVA: diva2:254657
Available from: 2009-10-09 Created: 2009-10-09 Last updated: 2017-12-13

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Wålinder, JanSjödin, IngemarAhlner, JohanBengtsson, Finn

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Wålinder, JanSjödin, IngemarAhlner, JohanBengtsson, Finn
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Faculty of Health SciencesPsychiatryDepartment of PsychiatryClinical PharmacologyDepartment of Clinical Pharmacology
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Human Psychopharmacology: Clinical and Experimental
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