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Is agomelatine effective for people with generalised anxiety disorder?
121 people, aged 18–65 years, with DSM-IV generalised anxiety disorder (69% female, mean age 42 years) (see online notes for exclusion criteria).
Five centres in Finland and six centres in South Africa; time period not stated.
Agomelatine (n = 63; 25–50 mg/day) or placebo (n = 58) for 12 weeks. Agomelatine dose was increased from 25 to 50 mg/day if there was an insufficient response after 2 weeks. This was done in a blinded fashion, using a dose adjustment algorithm.
Primary outcome: overall anxiety (HAM-A). Secondary outcomes: response (⩾50% reduction in HAM-A score); somatic anxiety, psychic anxiety, severity of illness, sleep and disability symptoms (HAM-A subscales, Clinical Global Impressions Scale, Leeds Sleep Evaluation Questionnaire and Sheehan Disability Scale); discontinuation effects in the week after discontinuation (Discontinuation Emergent Signs and Symptoms scale (DESS)). Last observation …