GSK 29060/356.
| Methods | Eight‐week, multicentre, randomised, double‐blind study | |
| Participants | Patients suffering from a major depressive episode according to DSM‐III‐R, with a baseline score on Hamilton Rating Scale for Depression‐17 Item (HDRS‐17) of at least 18, and an HDRS item 10 score of 1 or more. Age: 18 years or more Exclusion criteria: severe co‐existing disease not stabilised with medication, neurological disorders, DSM‐III diagnosis of schizophrenia, bipolar disorder or psychotic depression, or who met criteria for substance dependence and abuse within the past 6 months, ECT or fluoxetine within 3 months preceding baseline, any investigational drug within 30 days from baseline, MAOIs within 2 weeks preceding baseline, lithium treatment in the past 8 weeks, currently receiving Type 1C antiarrhythmics or oral anticoagulants, patients posing a suicidal risk, pregnant or lactating, hypersensitive to fluoxetine or patients with clinically significant abnormal laboratory values at retest oral screening. | |
| Interventions | Fluoxetine: 70 participants Paroxetine: 68 participants Fluoxetine dose: 20 mg/day Paroxetine dose: 20 mg/day | |
| Outcomes | Primary outcomes: HDRS and Hamilton Rating Scale for Anxiety (HAM‐A) Secondary outcomes: Clinical Global Impression Scale (CGI), including severity and improvement |
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| Notes | Funding: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information about randomisation procedure |
| Allocation concealment (selection bias) | Unclear risk | No information |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "double‐blind". No further information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blind". No further information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All ITT analyses used last observation carried forward (LOCF) data set. Number and reasons for dropout reported. Mean endpoint scores (HDRS) reported with standard deviations |
| Selective reporting (reporting bias) | Unclear risk | Most frequent side effects reported. Number of responders not reported |
| Other bias | Unclear risk | Funding: unclear information |