Leinonen 1999.

Methods	Eight‐week, double‐blind, multicentre, randomised study.
Participants	Patients fulfilling the DSM‐IV criteria for a major depressive episode according to the DSM‐IV check‐list with a total score of ≥ 22 on the Montgomery and Asberg Rating Scale for Depression (MADRS). Exclusion criteria: patients with a history or presence of bipolar disorder, depressive disorder (not otherwise specified), schizophrenia, adjustment disorder, schizotypal or borderline personality disorder, organic mental disorder, anxiety disorders preceding depression, or presence of eating disorders (anorexia or bulimia nervosa), post‐partum depression, epilepsy or a history of seizure disorder or treatment with anticonvulsant medication for epilepsy or seizures, alcohol or substance abuse during the lat 12 months, with actual risk of committing suicide defined as MADRS score 5 or 6 or assessed by investigators as being at high risk of committing suicide. Patients with a previous history or actual presence of any meaningful renal, hepatic, respiratory, cardiovascular or cerebrovascular disease or other serious, progressive physical disease, or with any clinically meaningful abnormal finding uncovered during the physical examination and/or clinically significant abnormal laboratory results at screen and still present at baseline. Non‐responders to antidepressant treatment. Patients participating in any other clinical trials or treated before the start of active treatment with MAO inhibitors (2 weeks), fluoxetine (4 weeks), citalopram (current episode), electroconvulsive therapy (3 months), benzodiazepines (2 weeks), other psychotropic drugs (1 week). Women pregnant or lactating, or women who intended to become pregnant during the course of the study were not eligible for participation.
Interventions	Citalopram: 133 participants. Mirtazapine: 137 participants. Citalopram dose range: 20‐60 mg/day (mean: 36,6 sd: 9,7) Mirtazapine dose range: 15‐60 mg/day (mean: 35,0 sd: 6,9)
Outcomes	Outcomes: mean change on MADRS, Hamilton Anxiety Scale (HAM‐A), Clinica Global impression (CGI), Leeds Sleep Evaluation Questionnaire (LSEQ) and Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) score.
Notes	This study was founded by Mirtazapine manufacturer (Organon).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were allocated to treatment with either mirtazapine or citalopram, according to the centrally prepared randomization list".
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "active medication was prepared as indistinguishable looking tablets and packaging was performed using a double‐dummy technique".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "efficacy analyses were based on Intention‐to‐treat (ITT) patient sample, thus including all randomized subject who received at least one dose of study medication and had at least one post‐baseline efficacy assessment on MADRS, using the Last Observation Carried forward (LOCF) method.
Selective reporting (reporting bias)	Unclear risk	No information reported.
Other bias	Unclear risk	Sponsorship bias cannot be ruled out.