TCAs versus placebo - National Center for Biotechnology Information

weeks of treatment.
Info on Screening Process: 198 enrolled. 178
entered double-blind treatment phase. Reasons
for exclusion unknown.
FEIGHNER1992B
Study Type: RCT
Study Description: 3-arm study; Paroxetine vs.
Imipramine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US
Notes: 120 participants entered the study.
Info on Screening Process: Unknown.
FEIGHNER1993
Study Type: RCT
Study Description: 3-arm study; Paroxetine vs.
Imipramine vs. Placebo
Type of Analysis: ITT; LOCF
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; multicentre, US.
Notes: Parallel groups.
Info on Screening Process: Unknown.
FERGUSON1994B
Study Type: RCT
Study Description: 3-arm study; Dothiepin vs.
Doxepin vs. Placebo
Type of Analysis: ITT; LOCF
Blindness: Double blind
Duration (days): Mean 70
Setting: Outpatients; multicentre, US.
Notes: 25 participants excluded from analyses;
23 didn't return after baseline and 2 withdrew
consent.
seizures, drug or alcohol misuse within the past year, or a
contraindication to imipramine such as glaucoma or chronic
urinary retention. Excluded after the wash-out phase if their
HDRS score was less than 20 or had decreased by 20% or
more.
Notes: Imipramine (45) + Placebo (48) = 93. Imipramine
(34F:11M) and Placebo (38F:10M).
Baseline: Fluoxetine Imipramine Placebo
HAM-D (21) 25.60 25.96 25.90
n= 116
Age:
Sex:
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Serious suicide risk, a primary psychiatric
diagnosis other than depression, a history of alcohol or other
substance misuse within the past 6 months, pregnancy or
breast feeding, clinically significant laboratory abnormalities,
or a medical contraindication to imipramine such as a history
of seizures, urinary retention or glaucoma.
Notes: Imipramine (40) + Placebo (37) = 77 participants.
Baseline: HAMD (21): Approx. 25 (graphical data).
n= 717
Age: Mean 40
Sex: 347 males 370 females
Diagnosis:
100% Major depressive disorder by DSM-II
Exclusions: Patients had any other primary psychiatric
diagnosis or progressive/unstable physical illness. Women
of childbearing potential were excluded for the initial part of
the study. During the latter stages of the trial, women not
using adequate contraception or who were lactacting were
excluded.
Notes: Imipramine (237) + Placebo (240) = 477
participants. Imipramine (112M:125F) and Placebo
(122M:118F).
Baseline: Paroxetine Imipramine Placebo
HAM-D 26.4 26.2 26.6
n= 579
Age: Mean 40
Sex: 214 males 340 females
Diagnosis:
100% Major depressive disorder by DSM-III-R
Exclusions: Active suicidal ideation or suicide attempts in the
last 12 months, schizophrenia, organic mental syndromes,
or seizure disorders, failure to respond to an adequate
course of antidepressant therapy, recent history of alcohol or
drug misuse, electroconvulsive therapy within 30 days of the
Data Used
Non-response 50% reduction in HRSD
Leaving treatment early due to side effects
Leaving treatment early for any reason
Data Not Used
HRSD-21 mean endpoint - no data
Data Used
Number reporting side effects
Leaving treatment early due to side effects
Leaving treatment early for any reason
Non-remission HRSD-17 < 10
HRSD-21 mean change
Data Used
Non-response 50% reduction in HRSD
Leaving treatment early for any reason
Leaving treatment early due to side effects
HRSD-17 mean change
Weight mean change (kg)
Group
Group
Group
Group
Group
Group
1 N= 40
Imipramine. Mean dose 111.3mg/day -
65mg/day-275mg/day.
2 N= 37
Placebo. Mean dose 5.46 capsules - No
details.
1 N= 237
Imipramine - Dose started at 80mg/day.
This was altered in the range 65-
145mg/day after the first week, 65-
210mg/day after the second week and in
the range 62-275mg/day from weeks 4-6.
2 N= 240
Placebo - No details.
1 N= 194
Dosulepin (dothiepin). Mean dose
140.7mg/day - 50mg/day days 1-3,
100mg/day days 4-7, and from thereafter
up to 150mg/day.
2 N= 192
Placebo - Unknown.
Funding; research.
Funding; unclear.
Funding; pharma (Boots
Pharmaceuticals, Inc.).
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