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Randomised controlled trial (RCT).
Single blind (assessors blinded).
Follow up period:
Fourteen weeks (treatment period only).
Eighteen primary practices and 23 psychiatric practices in Maryland, USA: enrolment 2001 to 2004.
235 outpatients with a primary diagnosis of DSM-IV non-psychotic major depressive disorder on entry to the STAR*D study, who did not achieve an adequate response (Quick Inventory of Depressive Symptomatology (QIDS-SR16) score ⩽5) or could not tolerate two previous drug regimens delivered in the first two phases of this RCT. Exclusions: primary diagnosis of obsessive compulsive or eating disorders; bipolar or psychotic disorders; conditions contraindicating the use of antidepressive medication; substance abuse needing hospitalisation for detoxification; prior non-response to antidepressive medication; pregnancy, or breastfeeding.
Mirtazapine (15 mg/day titrated up to …
For correspondence: Dr M Fava, Depression Clinical and Research Program, Massachusetts General Hospital, Bulfinch 351, 55 Fruit Street, Boston, MA 02114, USA;
Source of funding: National Institute of Mental Health.