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Ramy A Mahmoud
Correspondence to: Ramy A Mahmoud, ETHICON, Inc, PO Box 151, US Highway 22 West, Room E314, Somerville, NJ 08876, USA; rmahmou@ethus.jnj.com
QUESTION
Question:
How effective is augmentation with low-dose risperidone for treatment-resistant depression in adults?
Patients:
274 outpatients aged 18–65 years with DSM-IV major depressive disorder who did not respond to standard antidepressant monotherapy during 4 weeks’ treatment prior to randomisation (non-response defined as Clinical Global Impression-Severity of Illness (CGI-S) score ⩾4 and Carroll Depression Scale score ⩾20). Exclusions: pregnancy; substance or alcohol use disorder; current use of tricyclic antidepressant, monoamine oxidase inhibitor, antiepileptic, or mood stabiliser; suicidal risk; serious medical or neurological illness; treatment for attention deficit/hyperactivity disorder or narcolepsy.
Setting:
Outpatient clinics in public and private care settings and psychiatric centres in the USA; recruitment October 2004 to November 2005.
Intervention:
Six weeks’ treatment augmentation with low-dose risperidone (0.25 mg for the first 3 days, 0.5 mg on days 4–15, 1.0 mg on days 16–28) or placebo. If there was no response by day 29, dose could be increased to 2 mg daily at the investigator’s discretion or …
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