TCAs versus placebo - National Center for Biotechnology Information

criteria either at screening or at rescreening. presence of specific physical illness or other medical
contraindications for the use of imipramine, and presence of
a clinical state inconsistent with participating in the research
protocol.
ENTSUAH1994
Study Type: RCT
Study Description: 3-arm study; Imipramine vs.
Venlafaxine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Info on Screening Process: Unknown.
ESCOBAR1980
Study Type: RCT
Study Description: 3-arm study; Trazodone vs.
Imipramine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 28
Setting: Inpatients; Colombia.
Info on Screening Process: Unknown.
FABRE1980
Study Type: RCT
Study Description: 3-arm study; Alprazolam vs.
Imipramine vs. Placebo
Type of Analysis: Completer
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Info on Screening Process: Unknown.
Notes: Imipramine (57) + Placebo (62) = 119 participants.
Baseline: CBT IPT IMI-CM PLA-CM
HAM-D (17) 19.2 (3.6) 18.9 (3.9) 19.2 (5.0) 19.1 (3.7)
n= 213
Age: Mean 42
Sex: 71 males 142 females
Diagnosis:
100% Major depressive disorder by No details
Exclusions: Unknown.
Notes: Imipramine (71) + Placebo (78) = 149 participants.
Baseline: Unknown.
n= 40
Age: Mean 45 Range 25-66
Sex:
Diagnosis:
85% Depression by RDC
15% Double depression by RDC
Exclusions: No history of other psychiatric disorder or major
physical illness.
Notes: Imipramine (15) + Placebo (12) = 27 participants.
Imipramine (8F:7M) and Placebo (8F:4M). Double
depression = bipolar.
Baseline: Trazodone Imipramine Placebo
HAM-D (21) 30.8 31.3 30.9
n= 154
Age:
Sex:
Diagnosis:
100% Depression by No details
Exclusions: Not suffering primarily from primary depression,
were psychopathic, sociopathic or psychotic, were suffering
from bipolar, involutional or schizoaffective depressions, had
significant liver or kidney disease as determined by physical
examination, vital signs and laboratory tests, had
uncontrolled cardiovascular, pulmonary, endocrinological or
collagen diseases or glaucoma, or conditions where
imipramine is contraindicated, had a history of urinary
retention, paralytic ileus and convulsive disorders, were
sensitive to benzodiazepines or tricyclics or actively abusing
alcohol or other drugs, required other psychotropic
medication, hypnotics or analgesics containing narcotics,
received anticholinergic drugs or preparations containing
sympathicomimetic amines, were receiving guanethidine,
Data Used
MADRS mean change
HRSD-21 mean change
Notes: Cumulative mean changes given.
Data Used
Non-response 50% reduction in HRSD
Data Used
Leaving treatment early for any reason
Group
Group
Group
Group
Group
Group
1 N= 71
Imipramine - No details.
2 N= 78
Placebo - No details.
1 N= 12
Placebo - The starting dose was 4
capsules/day. One additional capsules
was permitted every second day
depending on clinical condition, and up to
a maximum of 12 capsules per day.
2 N= 15
Imipramine - 100-300mg/day.The starting
dose was 100mg/day. An additional 25mg
was permitted every second day
depending on clinical condition, and up to
a maximum of 300mg/day.
1 N= 52
Imipramine. Mean dose 128.4mg/day - No
details.
2 N= 51
Placebo - No details.
Funding; unclear. Work for
Clinical Biostatics, Wyeth-
Ayerst Research.
Funding; unclear.
Funding; unknown.
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