| Methods |
Six‐week randomised, double‐blind clinical trial |
| Participants |
Outpatients fulfilling DSM‐IV criteria for depressive episode, with a score of at least 18 on the Hamilton Rating Scale for Depression (HDRS) and to be free of psychotropic medication for at least 4 weeks before study entry.
Age range: 18‐55 years
Exclusion criteria: pregnancy, absence of contraception, current cognitive disorder in the last year, bipolar disorder, schizophrenia or schizotypal personality disorder, significant risk o suicide (two or more at the suicide item of the HDRS or to be judged to have significant suicidal ideation in the view of an investigator). |
| Interventions |
Fluoxetine: 20 participants
Crocus Sativus: 20 participants
Fluoxetine dose: 20 mg/day
Crocus sativus dose: 30 mg/day |
| Outcomes |
Primary outcome: change in the HDRS total score |
| Notes |
Funding: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomised in a 1:1 ratio using a computer‐generated code", no further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: "throughout the study the person who administered the medications, rater and patients were blind to assignments", no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: " throughout the study the person who administered the medications, rater and patients were blind to assignments", no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: " throughout the study the person who administered the medications, rater and patients were blind to assignments", no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Number of withdrawals reported, but reasons for drop‐out not clearly described. Baseline and end‐point scores reported only in figures |
| Selective reporting (reporting bias) |
Unclear risk |
Side effects not clearly reported |
| Other bias |
Unclear risk |
Funding: unclear |
