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Randomised controlled trial.
Six months (treatment period only).
Five academic medical centres (outpatient psychiatry clinics) in the US; 1997–2004.
Phase 1 (acute non-randomised treatment): 531 people aged 18–85 years with primary DSM-IV major depression (24-item Hamilton Rating Scale for Depression (HRSD) total score ⩾21) referred for bilateral electroconvulsive therapy (ECT). Phase 2 (maintenance treatment): 201 people with remission in phase 1 (⩾60% decrease from baseline in HRSD total score and HRSD score ⩽10 on two consecutive ratings), an HRSD score ⩽10 or less for 1 week without psychotropic medication, and modified Mini-Mental State Examination (mMMSE) …
For correspondence: Charles H Kellner, MD, Department of Psychiatry, UMDNJ New Jersey Medical School, 183 South Orange Avenue, BHSB Room F1436, Box 1709, Newark, NJ 07103, USA;
Sources of funding: National Institute of Mental Health grants from the Mayo Foundation, the Zucker Hillside Hospital, North Shore-Long Island Health System, the University of Texas Southwestern Medical Center at Dallas, the Medical University of South Carolina and from the University of Medicine and Dentistry of New Jersey – New Jersey Medical School.
Competing interests: Professor Freemantle has received funding for research, consulting and travel expenses from a number of manufacturers of pharmaceutical products for depression.
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