Carman 1991.
Methods | 6‐week, double‐blind, randomised, placebo wash‐out with elimination of placebo responders, number of participating centres unclear | |
Participants | Psychiatric outpatients meeting DSM‐III criteria for major depression, moderately to severe, having a minimum score of 18 on the 17‐item HAM‐D Age: no data Sex: no data Exclusion criteria: fertile females without adequate contraception, major or unstable medical problems, other psychiatric diagnosis, age < 18 years |
|
Interventions | Amitriptyline: 50 participants Placebo: 50 participants Amitriptyline dose: range 60 mg to 300 mg |
|
Outcomes | Primary outcome: 17‐item HAM‐D Secondary outcomes: MADRS, CGI, SDS |
|
Notes | Sponsor: no sponsor mentioned, but one of the authors is from Organon Inc. Response: no response data Remission: no remission data Only 17‐item HAM‐D depression change score 3‐arm study comparing mianserin, amitriptyline and placebo (total 150 participants) One author is also an co‐author of Wilcox 1994 and representative of Organon. Due to identical parameters like equal numbers of patients randomised, same study design and duration, equal dosing and almost identical response rates we had the suspicion, that both publications are describing the same trial, but there are also outcomes which are different like the mean baseline HAM‐D or the mean dose. So we finally decided that these trials were independent and included both. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomised, double‐blind active‐ and placebo‐controlled" |
Allocation concealment (selection bias) | Unclear risk | Not explained |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Randomised, double‐blind active‐ and placebo‐controlled", "identical capsules" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Randomised, double‐blind active‐ and placebo‐controlled", "identical capsules", no details on blinding of assessor |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It seems that not all drop‐outs have been reported. Modified ITT analysis (at least 14 days of treatment) and true ITT did not lead to different results |
Selective reporting (reporting bias) | High risk | Missing standard deviations |
Other bias | Low risk | No obvious other bias |