Amitriptyline is an efficacious antidepressant drug .
It is , however , also associated with a number of side effects .
Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences
BACKGROUND Amitriptyline is a tricyclic antidepressant that was synthesis ed in 1960 and introduced as early as 1961 in the USA , but is still regularly used .
It has also been frequently used as an active comparator in trials on newer antidepressants and can therefore be called a ' benchmark ' antidepressant .
However , its efficacy and safety compared to placebo in the treatment of major depression has not been assessed in a systematic review and meta- analysis .
OBJECTIVES To assess the effects of amitriptyline compared to placebo or no treatment for major depressive disorder in adults .
A controlled study of mianserin in moderately to severely depressed outpatients.
Following a 1-week , single-blind placebo washout , 150 patients were r and omized to double-blind treatment with daily doses of either mianserin  , 30 mg to 150 mg ;  amitriptyline , 60 mg to 300 mg ; or placebo , 1 to 5 capsules taken at bedtime ( qhs ) . Mianserin and amitriptyline were found to be comparable in efficacy , and both significantly more effective than placebo in the treatment of major depressive illness . Rating instruments , all of which showed significant improvement in the active drug groups over the placebo , included the 17- and 21-item Hamilton Rating Scale for Depression ( HAM-D ) , Montgomery and Asberg Depression Rating Scale ( MADRS ) , Self-rating Depression Scale ( SDS ) index , and the Clinical Global Impressions ( CGI ) Severity of Illness and Improvement rating scales . Furthermore , for most efficacy parameters in the efficacy-evaluable group , the earliest statistically significant difference vs. placebo could be observed at Visit 1 for the mianserin patients and at Visit 3 for the amitriptyline patients . The safety profile for mianserin was comparable with placebo with respect to laboratory values , electrocardiogram changes , vital signs , ophthalmologic evaluations , and most adverse clinical experiences . Complaints of somnolence and weight gain were comparable in the amitriptyline and mianserin groups . Mianserin was superior to amitriptyline in terms of vital signs ; anticholinergic effects ; and complaints of dizziness , dyspepsia , and tremor
Amitriptyline is an efficacious antidepressant drug .
It is , however , also associated with a number of side effects .
Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences
BACKGROUND Amitriptyline is a tricyclic antidepressant that was synthesis ed in 1960 and introduced as early as 1961 in the USA , but is still regularly used .
It has also been frequently used as an active comparator in trials on newer antidepressants and can therefore be called a ' benchmark ' antidepressant .
However , its efficacy and safety compared to placebo in the treatment of major depression has not been assessed in a systematic review and meta- analysis .
OBJECTIVES To assess the effects of amitriptyline compared to placebo or no treatment for major depressive disorder in adults .