Amisulpride in medium-term treatment of dysthymia: a six-month, double-blind safety study versus amitriptyline. AMILONG investigators.
Two hundred and fifty patients participated in a 6-month, double-blind study to evaluate safety and efficacy of a medium-term treatment with amisulpride 50 mg/day versus amitriptyline 25-75 mg/day in dysthymia. Patients in treatment groups (165 amisulpride; 85 amitriptyline) were well balanced for demographic and baseline characteristics. A total of 139 patients (93 amisulpride, 46 amitriptyline) completed the study with no statistically significant differences in reasons for premature termination between the two groups. A tendency towards a higher incidence of treatment-emergent adverse events with amitriptyline was observed (73% versus 64% amisulpride). In the amitriptyline group, a statistically significantly higher incidence of central nervous system (41% versus 24%, p=0.004) and autonomic nervous system disorders (45% versus 16%, p < 0.0001) was reported. Conversely, endocrine disorders were more frequent with amisulpride (18% versus 7%, p=0.023). Efficacy was a secondary end-point. Results of the symptom rating scales indicate that both drugs were equally effective: 60% and 62% of patients under amisulpride and amitriptyline, respectively, achieved a reduction > or = 50% of the Montgomery and Asberg Rating Scale total score at end-point. On the item 'global improvement' of the Clinical Global Impression, 67% of amisulpride and 68% of amitriptyline patients were rated as 'very much' or 'much' improved. Results of the present study in a large patient population further confirm the safe use of amisulpride in dysthymia and support its administration upon a medium-term treatment period.
Ravizza
L
L
Department of Neuroscience, School of Medicine, University of Torino, Italy.
D000328:Adult; D000368:Aged; D000077582:Amisulpride; D000639:Amitriptyline / Q000009:adverse effects* / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects* / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D019263:Dysthymic Disorder / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016037:Single-Blind Method; D013469:Sulpiride / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000929:Antidepressive Agents, Tricyclic; D014150:Antipsychotic Agents; D000639:Amitriptyline; D013469:Sulpiride; D000077582:Amisulpride