| Methods |
Amitriptyline vs Amylobarbitone vs placebo
RCT involving 21 GPs in Melbourne over a 6 month period |
| Participants |
N = 82. Inclusion criteria: Women over 15 years (mean age 37.7), persistent lower mood with depressive symptoms; sleep and appetite disturbances, loss of interest, inability to concentrate. Mean baseline HAMD = 17.4 (SD4.9) Exclusion criteria: organic brain disorder, schizophrenia, epilepsy, alcoholism and mental retardation. |
| Interventions |
Amitriptyline 75 mg per day, amylobarbitone 150 mg/day and placebo for 4 weeks |
| Outcomes |
23 drop outs. (82 started, 61 analysed) Results at 28 days: Amitriptyline 75mg n=13, HAMD mean=6.4 (SD 5.4), vs Amitriptyline 150 mg n=14, HAMD mean=5.1 (SD 4.9) vs Placebo n=18, HAMD mean=11.4 (SD 9.6)
At one week: Amitripyline 75mg n=13, HAMD mean=11.2 (SD 3.9) vs Amitriptyline 150mg n=14, HAMD mean=7.1 (SD 4.7) vs Placebo n=18, HAMD mean=14.2 (SD 6.2)
Side effects not leading to withdrawal included shakiness of legs or arms, dry mouth, blurred vision, fuzziness in the head drowsiness, restlessness, headache, pain in stomach (no difference between groups).
Adverse effects leading to withdrawal (11/82): Amitriptyline 75mg/day (4),
Amitriptyline 150mg/day (3), Placebo (4) |
| Notes |
Amitriptyline versus placebo.
Saw a psychiatrist for medication but also saw their GP during 4 weeks of study. Considered as being conducted by a psychiatrist |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
