Robinson 2000b.
| Methods | Parallel design Comparison of fluoxetine, nortriptyline and placebo. We are using the fluoxetine and placebo data Analysis: per protocol, number excluded from analyses varies Data provided for depressed and non‐depressed separately. We are labelling the depressed group as Robinson 2000a, and the non‐depressed group as Robinson 2000b (this trial) |
|
| Participants | Location: USA and Argentina Setting: mixed Treatment: 17 non‐depressed people, mean ± SD age 66 ± 13 years, 15 men Control: 16 non‐depressed people, mean ± SD age 67 9 years, 12 men Stroke criteria: all subtypes, diagnosis by clinical signs and CT (100%), stroke within 6 months of recruitment, aged 18 to 85 years of age Stroke on average 8 weeks (treatment) and 5 weeks (control) prior to randomisation Comparability of treatment groups: unclear Exclusion criteria: other significant medical illness, severe comprehension deficit, prior history of head injury, prior history of other brain disease (with the exception of stroke), participants on antidepressants (other than fluoxetine) were allowed to stop their antidepressant for a 2‐week washout period |
|
| Interventions | Treatment: fluoxetine 10 mg daily (3 weeks), 20 mg daily (3 weeks), 30 mg daily (3 weeks), 40 mg daily (3 weeks) Control: matched placebo Duration: treatment continued for 12 weeks Duration of follow‐up (end of treatment to end of study): 0 |
|
| Outcomes | Depression: change in scores from baseline to end of treatment on HDRS Additional: MMSE, JHFI Death AEs (method of reporting these was not stated) |
|
| Funding source | Funded by NIMH grants and grants from the Raul Carrea Institute of Neurological Research and Fundacion Perez Companc. Eli Lilly and company supplied the fluoxetine and placebo | |
| Notes | Note difference in time since stroke between groups Dates of recruitment not stated. Conflicts of interest not stated |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random‐number table |
| Allocation concealment (selection bias) | Low risk | Concealment held by independent person |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Matched placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT and per‐protocol |
| Selective reporting (reporting bias) | Low risk | Trial on www.strokecentre.org/trials |
| Other bias | Unclear risk | Note imbalance in time since stroke and in gender. |