Moreno 2006.
| Methods | Eight‐week randomised, double‐blind study | |
| Participants | Outpatients fulfilling DSM‐IV criteria for mild to moderate, non psychotic major depressive disorder, with a baseline score of at least 10 and a maximum score of 24 on the Hamilton Rating Scale for Depression (HDRS). Age range: 18‐65 years Exclusion criteria: patients with other types of depression, psychosis, personality disorders, bipolar disorders, suicidal ideation, uncontrolled organic disease, history of alcohol or drug abuse 1 year prior, abnormal laboratory tests or a history of seizures, treated with electroconvulsive therapy or have taken any investigational drug up to 30 days before screening. Patients who used MAO‐inhibitors 2 weeks before the enrolment, benzodiazepines in doses equivalent to diazepam 10mg/day 1 week before the enrolment and patients already treated with fluoxetine. | |
| Interventions | Fluoxetine: 20 participants Hypericum: 20 participants Fluoxetine dose: 20 mg/day Hypericum dose: 900 mg/day | |
| Outcomes | Primary outcome: change in the HDRS total score Seconday outcomes: Clinical Global Impression (CGI) Severity, Montgomery and Asberg Scale for Depression (MADRS), UKU side effects rating scale (UKU) |
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| Notes | Funding: by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised, 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 | Double blind, 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 | High risk | Number and reasons of withdrawals not clearly reported. Endpoint scores and responders reported only in figures |
| Selective reporting (reporting bias) | Unclear risk | SIde effects not reported. Secondary endpoint not reported |
| Other bias | High risk | Quote: "the authors are grateful to Marjan, for the financial support and donation of hypericum perforatum, and to Eli Lilly Brazil, for the donation of fluoxetine", this two pharmaceutical companies produce the two study drugs |