Benkert 1999.
Methods | Six‐week, randomised, double‐blind, multicentre study. | |
Participants | Outpatients meeting DSM‐IV criteria for major depression (no patients with bipolar disorder). Age range: 18‐70 years. | |
Interventions | Paroxetine: 136 participants. Mirtazapine: 139 participants. Paroxetine dose range: 20‐40 mg/day. Mirtazapine dose range:15‐45 mg/day. In case of severe insomnia chloral hydrate was permitted. |
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Outcomes | The measure used for response and remission in the review: Hamilton rating scale for depression (HDRS‐17). Other measures: Hamilton rating scale for anxiety (HAM‐A), Beck Depression Inventory (BDI), Welzil‐Kohnen Color Scales (WKFS), Short Form‐36, Clinical Global Impression (CGI) improvement, CGI‐severity. |
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Notes | Funding: mirtazapine manufacturer. Adverse events reported only if occurring in >= 5% of any treatment group. |
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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", "both drugs were given once daily, mirtazapine in the evening and paroxetine in the morning using a double dummy technique. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blind". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | More than 20% of the allocated patients to both of the intervention arms dropped out during the study. 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. A Last Observation Carried Forward (LOCF) analysis was performed for the endpoint assessment. |
Selective reporting (reporting bias) | High risk | Both the response and the remission outcomes at end of the acute‐phase treatment are reported with the proportion of the patients who achieved these. Standard deviations of change scores were not reported. Adverse events were reported only if occurring in >= 5% of any treatment group. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |