Feighner 1979.

Methods	Amitriptyline vs placebo RCT from 4 physicians in private practice in USA + 2 other university clinics
Participants	N=337 patients. 30% male. Mean age 40.2 yrs. Criteria of Feighner 1972 dysphoric mood + 5 of poor appetite, weight loss, loss of energy, agitation or retardation, loss of interest, diminished sexual drive, self reproach or guilt, poor concentration and thoughts of death or suicide. Also > 20 on HAMD, >14 on short Beck and >8 on Covi scale. Exclusions: schizophrenia, alcoholism, hysteria, antisocial personality, serious medical risks, no recent ECT or MAOI or tricyclic or tranquilliser within 5 days. 143 were unipolar and 33 bipolar. 161 not classified
Interventions	Amitriptyline 25mg 4 tablets to start increasing to 5 or 6 tabs over 4 weeks. Same for placebo. Assessment was by a psychiatrist
Outcomes	58 drop outs. Outcome: 50% reduction in HAMD score at end of study (approximated from graphs) amitriptyline 37/53 vs 13/30 placebo improved. Assume mean baseline score HAMD =36 (fig 1). At 4 weeks: Amitriptyline group mean 15.2 (SD 7.3) n=53 vs placebo = mean 21 (SD 9.6) n= 30 (see assumptions for SD in text). At 1 week: Amtriptyline HAMD mean 26.9 (SD 7.3) n=71 vs placebo HAMD mean 27 (SD 9.6) n=41. At 2 weeks: Amitriptyline mean 21.2 (SD 7.3) n=60 vs Placebo mean 25.7 (SD 9.6) n=35. The mean dose for Amitriptyline was 4.6 tablets; placebo 5.5 tablets. Side effects not necessarily leading to treatment withdrawal: Amitriptyline 12/93 and 3/50 for placebo. Actual effects not stated. Withdrawal due to treatment failure: Amitriptyline 6/93 and placebo 9/50. Treatment withdrawal for any reason: Amitriptyline 40/93 and 20/50 for placebo.
Notes	TCA vs placebo Assessments all done by a psychiatrist but presumed patients came from primary care although cannot be certain
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate