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


METHODS
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.


CONCLUSIONS
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.
Wålinder
Jan
J
Department of Psychiatry, Sahlgrenska University Hospital/Mölndal, Göteborg University, Sweden.
Prochazka
Jiri
J
Odén
Anders
A
Sjödin
Ingemar
I
Dahl
Marja-Liisa
ML
Ahlner
Johan
J
Bengtsson
Finn
F
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D003863:Depression / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008803:Mianserin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D000078785:Mirtazapine; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012189:Retrospective Studies; D013548:Sweden / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine