| Methods |
Eight‐week double‐blind, randomised trial |
| Participants |
Outpatients meeting DSM‐IV diagnostic criteria for major depression, with a minimum baseline score of 18 and not superior to 25 on the Hamilton Rating Scale for Depression‐17 Item (HDRS‐17).
Age range: 19‐55 years
Exclusion criteria: patients posed a significant risk of suicide at any time during participation, persons who scored greater than 2 on the suicide item of the HDRS, any clinical significant deterioration during the trial, pregnancy and women not using medically accepted means of birth control. |
| Interventions |
Fluoxetine: 20 participants
Petal of Crocus sativus: 20 participants
Fluoxetine dose: 10 mg/day
Petal of Crocus sativus dose: 15 mg/day |
| Outcomes |
Primary outcome: HDRS‐17, remission was defined as an endpoint score of 7 or less |
| Notes |
Funding: independent study |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "patients were randomised to receive capsule of petal of Crocus or fluoxetine in a 1:1 ratio using computer code", no further information |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
| 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: "capsules (...) did not have any different taste compared to fluoxetine", "the person who administered the medication, raters and patients were blind to assignment", not clear if blindness was successful |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "the person who administered the medication, raters and patients were blind to assignment", not clear if blindness was successful |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number of responders reported with denominator. Reasons for dropout not reported |
| Selective reporting (reporting bias) |
Unclear risk |
Mean endpoint scores and standard deviation reported only in figures. Side effects reported |
| Other bias |
Low risk |
Funding: independent study |
