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. 2014 Apr 3;2014(4):CD006531. doi: 10.1002/14651858.CD006531.pub2

Schnyder 1996.

Methods Phase III multicentre, double‐blind, randomised, parallel‐group study.
Participants Patients were in‐ or out‐patients of either sex, aged 18 to 65 years, had been diagnosed with major depression according to the DSM‐III‐R criteria, and had a score of at least 18 on the Hamilton rating scale for depression (HDRS‐21) on the day before the start of treatment.
Exclusion criteria were pregnancy or lactation period, severe co‐existing physical diseases, MAOI or neuroleptics shortly prior to the study, chronic lithium therapy, intolerance to tricyclic antidepressants, schizophrenia, dementia, or a history of ECT treatment, manic episodes or bipolar disorder. Before entering the study, all patients had to undergo a general medical examination.
Interventions Paroxetine: 37 participants.
Maprolitine: 34 participants.
Paroxetine dose range: 20‐40 mg/day.
 Maprolitine dose range: 50‐150 mg/day.
In case of sleep disturbances, the following concurrent medications were permitted: lormetazepam, dipotassium chloracepate, chloral hydrate, diazepam, flurazepam, oxazepam, bromazepam, flunitrazepam and zolpidem.
Outcomes HDRS, Montgomery and Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI). Total dropout, dropout due to side effects, dropout due to inefficacy. Number of patients experiencing at least one side effect, side‐effect profile.
Notes Reasons for withdrawal were reported.
Funding: paroxetine manufacturer.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomly assigned to treatment".
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "double‐blind study". No further details.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "double‐blind study". No further details.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No clear information about data analysis.
Selective reporting (reporting bias) High risk Rating scales scores at follow‐up assessments were not clearly reported. The denominators (for continuous outcomes) were unclear.
Other bias Unclear risk Sponsorship bias cannot be ruled out.