TCAs versus placebo - National Center for Biotechnology Information

Setting: Unclear; multicentre, US.
Info on Screening Process: Unknown.
SMITH1990
Study Type: RCT
Study Description: 3-arm study; Mirtazapine vs.
Amitriptyline vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: 10 participants (3 mirtazapine, 3
amitriptyline and 4 placebo) took medication for
less than 2 weeks and were not included in
efficacy analysis.
Info on Screening Process: Unknown.
SPRING1992
Study Type: RCT
Study Description: 3-arm study; Amitriptyline vs.
Clovoxamine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 28
Setting: Outpatients; US.
Info on Screening Process: Unknown.
STASSEN1993
Study Type: RCT
Study Description: 3-arm study; Amitriptyline vs.
Oxaprotiline vs. Placebo
Type of Analysis: ITT; LOCF
Blindness: Double blind
Duration (days): Mean 40
Setting: Unclear; multicentre, US.
Notes: Says it is a meta-analysis. Appears to be
a secondary analysis of an earlier study.
Info on Screening Process: Unknown.
THOMPSON2001B
Exclusions: Unknown.
Notes: Imipramine (100) + Placebo (72) = 172 participants.
Baseline: Unknown.
n= 150
Age: Mean 43
Sex: 64 males 86 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Primary diagnosis of schizophrenia, atypical
depression, anxiety, adjustment disorder, bipolar disorder, if
they were known drug or alcohol misusers or had known
active suicidal tendencies of known cognitive deficiencies.
Free of significant renal, hepatic, respiratory, cardiovascular,
or cerebrovascular disease, free of narrow angle glaucoma,
prostatic hypertrophy, and seizure disorders, and with no
clinically relevant abnormal laboratory values or significantly
abnormal ECG findings.
Notes: Amitriptyline (47) + Placebo (46) = 93 participants.
Baseline: Mirtazapine Amitriptyline Placebo
HAM-D 17 23.4 23.7 23.3
n= 35
Age: Mean 35
Sex: 13 males 22 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Women who were pregnant or of childbearing
potential and not taking effective contraceptive measures,
patients whose depression was secondary to another
psychiatric disorder, and patients with significant organic
disease or drug dependency.
Notes: Amitriptyline (10) + Placebo (15) = 25 participants.
Amitriptyline (2M:8F) and Placebo (6M:9F).
Baseline: Amitriptyline Clovoxamine Placebo
HAM-D (21) 25.2 (2.8) 24.2 (2.3) 24.8 (4.5)
n= 429
Age: Range 17-73
Sex: 154 males 275 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Unknown.
Notes: Amitriptyline (120) + Placebo (189) = 309
participants.
Baseline: Unknown.
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Non-response 50% reduction in HRSD
MADRS mean change
HRSD-17 mean change
Data Used
HRSD-21 mean endpoint
Data Used
Leaving treatment early due to side effects
Non-response 50% reduction in HRSD
Data Not Used
HRSD-21 mean endpoint - no data
Group
Group
Group
Group
Group
Group
Group
1 N= 47
Amitriptyline. Mean dose 111mg/day -
Week 1: max 80mg/day, week 2: max
160mg/day, and weeks 3-6: max
280mg/day.
2 N= 46
Placebo. Mean dose 4.6 capsules/day -
Week 1: 2 capsules/day, week 2: 4
capsules/day and weeks 3-6: seven
capsules/day.
1 N= 10
Amitriptyline. Mean dose 114 mg/day - 50-
350 mg/day.
2 N= 15
Placebo - No details.
1 N= 189
Placebo - No details.
2 N= 120
Amitriptyline - Weeks 1 and 2: 75-
225mg/day. Kept at 225mg/day thereafter.
3 N=
Funding; unknown but
suspect pharma.
Funding; unknown.
Funding; unclear.
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