Dalery 2001.
Methods | Six‐week, double‐blind, randomised, multicentre study. | |
Participants | Inpatients and outpatients meeting DSM‐III‐R criteria for major depression with a minimum score of 25 on the Montgomery and Asberg Depression Rating Scale (MADRS) rating scale. Age: older than 60 years. | |
Interventions | Paroxetine: 54 participants. Mianserin: 62 participants. Paroxetine dose range: 20 mg/day. Mianserin dose range: 30 mg/day. No other psychoactive drugs were used except for patients who had initiated benzodiazepines within 14 days before the screening visit. |
|
Outcomes | MADRS, Mini Mental State Examination (MMSE), Aubin Jouvent Rating Scale (AJRS). Total dropout, dropout due to side effect, dropout due to lack of efficacy. Tolerability profile. |
|
Notes | None. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized". No further details. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double blind". No further details. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study endpoint: 11/54 missing from Paroxetine group; 9/62 missing from control group. Efficacy analyses were based on the Intention‐to‐treat (ITT) patients sample, including all randomly assigned patients who received at least one dose of study medication and had at least one post‐baseline efficacy assessment. |
Selective reporting (reporting bias) | High risk | Side‐effect profile incomplete. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |