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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

GlaxoSmithKline 1998.

Study characteristics
Methods Parallel group
Analysis: according to treatment group
Participants Location: not stated
Setting: not stated
Stroke criteria: "documented diagnosis of stroke within 12 months prior to screening"
Mood: MADRS score > 17
Treatment: 112 people, age 64.3 ± 11.4 years, 61 men
Control: 117 people, 65.6 ± 10.5 years, 64 men
Excluded: concurrent psychiatric disorders, concurrent psychotropic pharmacotherapy, patients who posed a suicidal risk, patients with substance abuse/dependence, concurrent psychotropic pharmacotherapy, MMSE < 24, participating in another clinical trial, serious medical condition or clinically significant finding on screening or baseline evaluation that would preclude the administration of paroxetine and an intolerance to paroxetine
Interventions Treatment: paroxetine 20 to 50 mg daily
Control: placebo (not stated whether matching)
Duration of treatment: 8 weeks
Duration of follow‐up (treatment to study end): 0 weeks
Outcomes Change from baseline to endpoint in MADRS
Proportion of participants scoring < 8 on the MADRS total score at the endpoint (we used this in our analysis)
Changes from baseline to endpoint on the BI
Change from baseline to endpoint on RS score
Change from baseline to endpoint on the Clinical Global Improvement Severity of Illness Score (CGI‐S Proportion of responders based on CGI‐Global Improvement (CGI‐G) score (score of < 4) at endpoint
GI side effects reported, but unclear whether these are 'events' or 'participants', so we cannot use these data. It is not clear how the side effects were collected
Withdrawal from study
Funding source Source of funding not stated, but we assume it was funded by GlaxoSmithKline
Notes Study period 29 August 1998 to 15 October 1999. Conflicts of interest not stated. Study number PAR625. Date updated: 11 March 2005
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation method not described
Allocation concealment (selection bias) Unclear risk Allocation concealment: not described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding not described, used placebo but not stated whether identical
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinding not described
Incomplete outcome data (attrition bias)
All outcomes High risk 20 in each group dropped out
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Unclear risk Insufficient information to make clear judgement