Thompson 1989.
Methods | Dothiepin vs placebo. RCT from 7 GPs in the United Kingdom | |
Participants | N=52. (6 men and 46 women). Mean duration of depression 9.9 weeks. Diagnosed by GPs by their usual criteria, not had treatment for depression in previous 6 months. Exclusions: pregnant, breastfeeding, allergy to Dothiepin, glaucoma, urinary retention, epilepsy, cardiovascular disorder or impaired renal or hepatic function. Also excluded were antipsychotic treatment in the past 5 years, requiring referral to hospital or immediate medication, or unlikely to be able to complete self rating questionnaires. Participants were classified post‐hoc into categories according to Research Diagnostic criteria for major depression and endogenous depression and the Newcastle index for endogenous depression. 58% of patients had major depression. | |
Interventions | 75mg of Dothiepin which could be increased to 150 mg after 2 weeks or placebo for 4 weeks. HAMD in Dothiepin group mean = 6.6 (SD 7.3) n=20 & placebo group mean = 9.5 (SD 9.6) n=21. | |
Outcomes | 21% drop outs by 2 weeks. Using a last value carried forward there were 20 patients on Dothiepin and 21 patients on placebo. At 4 weeks: HAMD in Dothiepin group n=20 mean = 9.0 (SD 7.3) vs placebo group n=21, mean = 10 (SD 9.6). At 3 weeks: n=21 mean = 9.5 (SD 7.3) vs n=20 mean = 10 (SD 9.6). At 2 weeks the HAMD in the Dothiepin group n=20 mean = 11 (SD 7.3) vs placebo n= 21 mean = 11 (SD 9.6). At one week for Dothiepin n=20 mean =16, (SD 7.3) vs placebo n=21 mean = 15 (SD 9.6) | |
Notes | GPs did the assessments. Patients in the study were very similar to patients given antidepressants in general practice. The author is not sure if the data is available but is happy with our approximations of the SDs |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |