| Methods |
Amitriptyline vs placebo vs L‐tryptophan vs combination L‐tryptophan and amitriptyline
RCT in 5 Scottish group general practices. |
| Participants |
N=115. Amitriptyline n=31 placebo n=28 (2 other arms L‐tryptophan n=29; combination Amitriptyline + L‐tryptophan n=27)
127 women & 34 men. Patients 18‐65 yrs
HMAD of ?12, depressed for? 2 weeks & considered by their GPs to need antidepressant medication but not need psychiatric referral.
Exclusions:
Tricyclic antidepressants in previous 2 weeks or contraindications to tricyclics |
| Interventions |
1 week run‐in period then 25 mg amitriptyline 3x daily for 1 week then 2 tablets 3 x daily for remaining 11 weeks.
Could also take diazepam 5mg or nitrazepam as hypnotic but had to continue this throughout study.
2 other arms to study which involved amitriptyline + tryptophan & tryptophan. Only those on active medication had blood levels for amitriptyline & tryptophan. 12 week duration |
| Outcomes |
37% (43) drop outs.
At 12 weeks HAMD for amitriptyline group mean = 4.9 (SD 4.9) n=21 vs placebo group mean = 7.93 (SD 4.2) n=15.
At 4 weeks: Amitriptyline group n=26 mean = 6.85 (SD 7.3) vs placebo group n=19 mean = 11.55 (SD 9.6).
At 12 weeks: complete remission (i.e. a fall of 4 on HAMD) 67% (14/21) in amitriptyline group vs 33% (5/15) in placebo group (estimates from graphs).
80% in active group had positive blood levels for amitriptyline.
Side effects not necessarily leading to withdrawal: amitriptyline 7/31 vs placebo 0/28
Adverse effects leading to withdrawal: amitriptyline 7/31 vs placebo 0/28
Withdrawal due to treatment failure: Amitriptyline 0/31 vs placebo 8/28
Treatment withdrawal for any reason: Amitriptyline 10/31 vs placebo 13/28 |
| Notes |
Alternating visit assessments done by psychiatrist and patient's own GP 2‐weekly. Good correspondence of assessments. Research psychiatrist ratings used in analysis (Weeks 0,4, 8 and 12). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
