Efficacy and safety of amisulpride 50 mg versus paroxetine 20 mg in major depression: a randomized, double-blind, parallel group study

• Published in: International clinical psychopharmacology Vol. 17; no. 1; pp. 27 - 32
• Main Authors: CASSANO, G. B, JORI, M. C
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 2002
• Subjects: Adolescent; Adult; Aged; Antidepressive Agents, Second-Generation - adverse effects; Antidepressive Agents, Second-Generation - therapeutic use; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Biological and medical sciences; Depressive Disorder - drug therapy; Depressive Disorder - psychology; Double-Blind Method; Female; Humans; Male; Medical sciences; Middle Aged; Neuropharmacology; Outpatients; Paroxetine - adverse effects; Paroxetine - therapeutic use; Pharmacology. Drug treatments; Psychiatric Status Rating Scales; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Sulpiride - adverse effects; Sulpiride - analogs & derivatives; Sulpiride - therapeutic use; Mood disorder; Human; Paroxetine; Psychotropic; Toxicity; Amisulpride; Controlled therapeutic trial; Depression; Long term; Chemotherapy; Treatment; Piperidine derivatives; Antidepressant agent; Benzamide derivatives; Comparative study
• ISSN: 0268-1315
• DOI: 10.1097/00004850-200201000-00004

The efficacy of amisulpride in depressive disorders has been demonstrated in dysthymia and in double depression. Limited data are available in major depression. A randomized, double-blind, parallel group, multicentre study was set up to compare the efficacy and tolerability of amisulpride (50 mg o.d.) and paroxetine (20 mg o.d.) for 8 weeks in 272 patients with major depression (DSM-IV and baseline Hamilton Depression Rating Scale (HAMD) score > or = 18). The study was designed as a non-inferiority trial based on the proportion of responders (> or = 50% decrease in HAMD total score) at end-point, with a maximal allowable difference of 15%; secondary end-points included HAMD total and cluster scores, Montgomery and Asberg Depression Rating Scale score and responders rates and Clinical Global Impression improvement. The tolerability evaluation was based on incidence of adverse events and routine laboratory tests. The results did not disclose statistically significant differences between treatments, although the hypothesis of an efficacy difference between the two treatments within the set limit at day 56 could not be accepted. The issue of non-inferiority trials is discussed.