| Methods |
Six‐week randomised, double‐blind multicentre study |
| Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depressive episode, with a score of at least 21 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17) and a score of at least 2 on the HDRS‐17 item 1.
Age range: 18‐75 years
Exclusion criteria: bipolar disorder, depressive disorder NOS, anxiety disorder within the last 2 years, schizophrenia, adjustment disorder, schizotypal or borderline personality disorder, eating disorder within the last 2 years, epilepsy, treatment with anticonvulsive medication for seizures, alcohol or substance abuse in the previous year, post‐partum depression within 1 year after delivery, high risk of suicide, unstable medical conditions, non‐responders to antidepressant treatments, use of MAOI within 2 weeks, previous use of fluoxetine for the current episode of depression, ECT within 3 months, continuous use of benzodiazepines, pregnancy, lactation, absence of contraception. |
| Interventions |
Fluoxetine: 67 participants
Mirtazapine: 66 participants
Fluoxetine dose range: 20‐40 mg/day
Mirtazapine dose range: 15‐60 mg/day
Temazepam (20 mg) oxazepam (15 mg) and nitrazepam (5 mg) were allowed |
| Outcomes |
HDRS‐17, Clinical Global Impression (CGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q‐LES‐Q) |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "patients were allocated to treatment with either mirtazepine or fluoxetine, according to the centrally prepared randomisation list", 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 |
Quote: "active medication was prepared as indistinguishable looking tablets and packaging was performed using a double dummy technique", 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 |
Unclear risk |
Scores reported without denominators. Reason and numbers of dropouts reported |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse events occurred in more than 5% of the sample reported. Endpoint scores not reported |
| Other bias |
High risk |
Quote: "supported by a clinical research grant from NV Organon, Oss, The Netherlands" and this company produces mirtazapine |
