TCAs versus placebo - National Center for Biotechnology Information

FABRE1992
Study Type: RCT
Study Description: 3-arm study; Paroxetine vs.
Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: 120 participants entered the study. 111
included in efficacy analyses.
Info on Screening Process: Unknown.
FABRE1996
Study Type: RCT
Study Description: 3-arm study; Fluvoxamine
vs. Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: F (46), I (48) and P (44) in ITT sample.
Info on Screening Process: 235 participants
screened; 150 entered (50 participants/group).
FEIGER1996A
Study Type: RCT
Study Description: 3-arm study; Imipramine vs.
Geripone vs. Placebo
Type of Analysis: ITT; LOCF
Blindness: Double blind
Duration (days): Mean 56
Setting: Outpatients; US
Info on Screening Process: Unknown.
propranolol, a methyldopa or thyroid medications, or could
not read of understand the symptoms check list.
Notes: Imipramine (52) + Placebo (51) = 103 participants.
Baseline: Unknown.
n= 111
Age: Mean 36
Sex: 42 males 69 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Another primary psychiatric diagnosis, a history
of alcohol or drug misuse within the previous 6 months, an
unstable hepatic, renal, respiratory or cardiovascular
disorder. History of glaucoma, urinary retention or a known
allergy to imipramine. Pregnant or breastfeeding women.
Women not currently using a medically acceptable form of
contraception.
Notes: Imipramine (37) + Placebo (36) = 73 participants.
Imipramine (12M:25F) and Placebo (13M:23F).
Baseline: Paroxetine Imipramine Placebo
HAM-D (21) 29.7 (0.64) 27.8 (0.65) 28.8 (0.66)
n= 150
Age:
Sex: 33 males 105 females
Diagnosis:
100% Major depressive disorder by DSM-III-R
Exclusions: Any other primary psychiatric diagnosis, an
unstable medical condition, clinically significant abnormal
laboratory findings and patients who demonstrated a
placebo response during the washout phase.
Notes: Imipramine (48) + Placebo (44) = 92 participants.
Imipramine (8M:40F) and Placebo (14M:30F) in ITT sample.
Baseline: Fluvoxamine Imipramine Placebo
HAM-D (21) 27.7 26.5 26.0
MADRS 30.6 30.6 29.5
n= 123
Age: Mean 40
Sex: 36 males 45 females
Diagnosis:
100% Major depressive disorder by DSM-III-R
Exclusions: Pregnant or lactating or sexually active and able
to bear children but not using adequate methods of
contraception. Axis I psychiatric diagnosis, delusions or
hallucinations during the current episode of depression, high
probability of needing other treatments during the course of
the study, significant current medical conditions, meeting
DSM-III-R criteria for psychoactive substance use disorder
within the prior 12 months, allergy or hypersensitivity to
azaperones or tricyclic antidepressants, significant suicide
Data Used
MADRS mean change
HRSD-21 mean change
Data Not Used
Leaving treatment early for any reason - no
data
Notes: SDs for mean HRSD very small and gave
high heterogeneity - convered to Ses and now no
heterogeneity - assume error in labelling in the
paper
Data Used
Number reporting side effects
Leaving treatment early due to side effects
Leaving treatment early for any reason
Non-response 50% reduction in HRSD
MADRS mean change
HRSD-24 mean change
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Number reporting side effects
MADRS mean endpoint
Data Not Used
HRSD-21 mean endpoint - no data
HRSD-17 mean endpoint - no data
Notes: HAM-D 28 used where 21 denoted.
Group
Group
Group
Group
Group
Group
1 N= 37
Imipramine. Mean dose 135.2mg/day -
Started at 80mg/day. Could be lowered to
65mg/day after the first week. The
maximum dose could be increased to
275mg/day.
2 N= 36
Placebo - No details.
1 N= 48
Imipramine - 72-182 mg/day. Maximum
dose 240mg/day. The initial dose was
40mg/day which was increased by
40mg/day every 3-4 days to a maximum
dose of 240mg/day over a 3 week period
as tolerated. Minimum dose of 80mg/day
for those who could not tolerate max daily
dose.
2 N= 44
Placebo - No details.
1 N= 41
Imipramine - Days 1-2: 50mg/day, days 3-
7: 100mg/day and 50-300mg/day
thereafter.
2 N= 40
Placebo - Days 1-2: 1 capsule/day, days
3-7: 2 capsules/day and up to 6
capsules/day thereafter.
Funding; unknown.
Funding; pharma (Solvay
Pharmaceuticals).
Funding; unclear.
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