Mirtazapine naturalistic depression study (in Sweden)-MINDS(S): clinical efficacy and safety

• Published in: Human psychopharmacology 2006-04, Vol.21 (3), p.151-158
• Main Authors: Wålinder, Jan, Prochazka, Jiri, Odén, Anders, Sjödin, Ingemar, Dahl, Marja-Liisa, Ahlner, Johan, Bengtsson, Finn
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antidepressive Agents, Tricyclic - adverse effects; Antidepressive Agents, Tricyclic - therapeutic use; Body Mass Index; Depression - drug therapy; Dose-Response Relationship, Drug; Drug Evaluation; Drug Toxicity; Drug-Related Side Effects and Adverse Reactions; Farmaceutisk vetenskap; Female; Humans; Longitudinal Studies; major depression; Male; MEDICIN; Medicin och hälsovetenskap; MEDICINE; Mianserin - adverse effects; Mianserin - analogs & derivatives; Mianserin - therapeutic use; Mianserin/adverse effects/analogs & derivatives/therapeutic use; Middle Aged; mirtazapine; naturalistic study design; Neurologi; Neurology; Pharmaceutical Sciences; Prospective Studies; Psychiatric Status Rating Scales; Psychiatry; Psychology; Psykiatri; Psykologi; Retrospective Studies; selection bias; Sweden - epidemiology; Time Factors; Treatment Outcome; trials; venlafaxine
• ISSN: 0885-6222; 1099-1077; 1099-1077
• DOI: 10.1002/hup.753

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.