TCAs versus placebo - National Center for Biotechnology Information

Study Type: RCT
Study Description: 3-arm study; Paroxetine vs.
Imipramine vs. Placebo.
Type of Analysis: Unclear
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Info on Screening Process: 120 entered; 102
completed.
COHN1992
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 study; 128
excluded from analysis. Main reason was use
of prohibited concomitant medication.
Info on Screening Process: Unknown.
COHN1996
Study Type: RCT
Study Description: 3-arm study; Nefazodone vs.
Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 56
Setting: Outpatients; US.
Notes: Parallel group design. 128 participants
entered study; 119 included in ITT analyses.
Info on Screening Process: Unknown.
DOMINGUEZ1981
Study Type: RCT
Study Description: 3-arm study; Amoxapine vs.
Imipramine vs. Placebo
Type of Analysis: Unsure
Blindness: Double blind
Duration (days): Mean 42
n= 120
Age:
Sex:
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Patients with a primary diagnosis of
schizophrenia; atypical type; anxiety as the primary disorder;
disorders of adjustment; manic depressive illness; alcohol or
drug misuse; or acute or unstable medical conditions.
Pregnant or lactating women and women of childbearing
potential not taking birth control precautions.
Notes: Imipramine (40) + Placebo (40) = 80 participants.
Baseline: Unknown.
n= 102
Age: Mean 42
Sex: 42 males 60 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Unstable systemic medical condition or clinically
significant abnormal laboratory values at the initial
evaluation. History of seizure disorder, alcohol or drug
misuse within 6 months prior to the study, a known allergy to
imipramine, or a history of glaucoma or prostatic
hypertrophy. Women were excluded if they were pregnant,
breast-feeding, or not using a medically acceptable form of
contraception.
Notes: Imipramine (31) + Placebo (36) = 67 participants.
Imipramine (12M:19F) and Placebo (19M:17F).
Baseline: Paroxetine Imipramine Placebo
HAM-D (17) 24.9 (0.72) 24.5 (0.71) 25.6 (0.71)
n= 119
Age: Mean 39
Sex: 33 males 86 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Unknown.
Notes: Imipramine (38) + Placebo (42) = 80 participants.
Imipramine (29F:9M) and Placebo (27F:15M).
Baseline: Nefazadone Imipramine Placebo
HAM-D (17) 22.8 23.6 23.4
n= 97
Age: Mean 41 Range 21-64
Sex: 38 males 59 females
Diagnosis:
100% Depression by No details
Exclusions: Treatment with any psychoactive drug within 7
Data Used
Number reporting side effects
Leaving treatment early for any reason
Leaving treatment early due to side effects
Data Not Used
HRSD-17 mean endpoint - no data
Data Not Used
Leaving treatment early for any reason - no
data
MADRS mean endpoint - no data
HRSD-17 mean endpoint - no data
Data Used
HRSD-17 mean change
Data Used
Number reporting side effects
Leaving treatment early for any reason
Data Not Used
HRSD-21 mean change - no data
Group
Group
Group
Group
Group
Group
Group
1 N= 31
Imipramine - 65-275mg/day. Received
medication in the morning and at bedtime.
2 N= 36
Placebo - No details.
1 N= 31
Imipramine. Mean dose 144.9mg/day - 65-
275mg/day. Treatment started with
80mg/day.
2 N= 36
Placebo - No details.
1 N= 38
Imipramine. Mean dose 126mg/day - 100-
300mg/day.
2 N= 42
Placebo - No details.
1 N= 38
Imipramine. Mean dose 102.5mg/day - 50-
200mg/day. Initial daily dose was 50-
75mg/day, and was escalated to a daily
dose of 100-150mg by the beginning of
the second week depending the patient's
response and side effects. The maximum
dose was 200mg/day.
Funding; unknown.
Funding; unclear.
Funding; part-pharma
(Bristol-Myers Squibb U.S.
Pharmaceuticals).
Funding; unknown.
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