GlaxoSmithKline 1998.
Study characteristics | ||
Methods | Parallel group Analysis: according to treatment group |
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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 |
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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 |
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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 |
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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 |