| Methods |
Eight‐week double‐blind, randomised study |
| Participants |
Patients fulfilling DSM‐III‐R criteria for major depression (single or recurrent episode, with or without melancholia and without psychotic features).
Age range: 18‐65 years
Exclusion criteria: clinically relevant disease, clinically significant changes on the ECG, lifetime history of hypomania/mania, psychotic disorder, dementia, borderline or antisocial personality disorders, history of a serious suicidal attempting the past 12 months, pregnancy or lactation, non‐responders to at least two trials of antidepressant treatment in the past, use of fluoxetine in the past 6 months or use of another investigational drug within one month prior to the baseline visit. |
| Interventions |
Fluoxetine: 35 participants
Pramipexole 1 mg: 35 participants
Pramipexole 5 mg: 33 participants
Placebo: 35 participants
Fluoxetine dose: 20 mg/day |
| Outcomes |
Primary outcomes: Hamilton Rating Scale for Depression (HDRS‐17), Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) Severity
Secondary outcomes: Beck Depression Inventory, CGI Improvement |
| Notes |
Funding: by industry |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: “randomised clinical trial”, 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 other information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no other information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "results are reported for the observed‐case analysis, for which no missing data were replaced". Number randomised, and number lost during follow‐up reported |
| Selective reporting (reporting bias) |
Unclear risk |
Scores reported without standard deviations. Adverse events were reported with a frequency of at least 10% |
| Other bias |
High risk |
Authors' affiliation was in Pharmacia&Upjohn Inc, and this company produces pramipexole |
