Smeraldi 1998.

Methods	Twelve‐week randomised, double‐blind multicentre study
Participants	Outpatients fulfilling DSM‐III‐R criteria for dysthymia or a single episode of major depression partial remission, with a score between 14 and 26 on the Montgomery–Åsberg Depression Rating Scale (MADRS). Age range: 18‐70 years Exclusion criteria: experience of inefficacy or intolerance to the study drug, suicidal risk, abuse or dependence on psychoactive substances, use of antidepressants or psychoactive drug in the previous 2 weeks, discontinuation of continuous or occasional use of benzodiazepines in the previous 2 weeks, need for psychoactive agents other than the study drug, severe debilitation, clinically relevant concomitant disease, cancer, pheochromocytoma, Parkinson's syndrome, pregnancy, absence of contraception, previous evidence of poor compliance, participation in a clinical trial in the previous 6 months.
Interventions	Fluoxetine: 139 participants Amisulpride: 142 participants Fluoxetine dose: 20 mg/day Amisulpride dose: 50 mg/day
Outcomes	Primary outcome: a reduction of at least 50% on the MADRS total score Secondary outcomes: change at endpoint on MADRS, Hamilton Rating Scale for Anxiety (HAM‐A), Sheean Disability Scale (SDS)
Notes	Funding: by industry
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised, no further information
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Double blind, no further information
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double blind, no further information
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Double blind, no further information
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "a total of 281 patients were included. The intention to treat analysis consisted of 268 patients". Scores at rating scales were reported without denominators. Number and reasons for dropout were reported
Selective reporting (reporting bias)	Unclear risk	Treatment emergent adverse events reported. Endpoint scores not reported
Other bias	High risk	Synthelabo Clinical Research (Limito di Pioltello, Milano) participated at the study, and this company produces amisulpride