Kramer 1998.
Methods | Six‐week, randomised, double‐blind, placebo‐controlled study. | |
Participants | Out‐patients with a DSM‐IV diagnosis of major depression disorder (single or recurrent), a current episode of depression lasting at least 4 weeks (but less than 2 years) a score ≥22 (moderately depressed) on the Hamilton rating scale for depression (HDRS‐17), a score ≥15 (moderately high anxiety) on the Hamilton rating scale for anxiety (HAM‐A) and a score ≥4 (moderately ill) on the Clinical Global Impression (CGI) Severity. Patients considered at risk for suicide or violence were excluded. | |
Interventions | Paroxetine:72 participants. Aprepitant (MK‐869): 71 participants. Paroxetine dose: 20 mg/day. Aprepitant (MK‐869): 300 mg/day. |
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Outcomes | HDRS‐21, HAM‐A, CGI‐S. | |
Notes | Funding: aprepitant manufacturer. | |
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 | Unclear risk | More than 20% of participants in each arm abandoned the study prematurely. |
Selective reporting (reporting bias) | High risk | Outcomes data not clearly reported. Only side effects with an incidence of > or = 5% were reported. |
Other bias | Unclear risk | Sponsorship bias cannot be ruled out. |