TCAs versus placebo - National Center for Biotechnology Information

unavailable for follow-up. known to be sensitive to benzodiazepines or
antidepressants or actively abusing alcohol or other drugs,
requiring other psychotropic medications, anticholinergics,
sympathomimetic amines, guanethidine, propranolol,
methyldopa or thyroid medications.
RICKELS1987
Study Type: RCT
Study Description: 4-arm study; Diazepam vs.
Alprazolam vs. Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Info on Screening Process: Unknown.
RICKELS1991
Study Type: RCT
Study Description: 4-arm study; Imipramine vs.
Adinazolam vs. Diazepam vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: Between-participants design.
Info on Screening Process: Unknown.
ROFFMAN1982
Study Type: RCT
Study Description: 3-arm study; Oxaprotiline vs.
Amitriptyline vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 28
Setting: Outpatients; USA.
Notes: Parallel groups.
Notes: Amitriptyline (124) + placebo (130) = 254
participants.
Baseline: HAM-D (21): 26.6 (5.4) (ALL)
n= 241
Age: Mean 39
Sex: 92 males 149 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Psychopathy or psychosis, bipolar, involutional,
schizoaffective, or secondary depression, severe liver or
kidney disease, uncontrolled cardiovascular, pulmonary,
endocrinological, or collagen diseases, glaucoma, history of
urinary retention, paralytic ileus, convulsive disorders, and
any disorder contraindicating the use of tricyclic medication.
Patients known to be sensitive to benzodiazepines or
antidepressants, actively abusing alcohol or other drugs, or
requiring other psychotropic medications, anticholinergics,
guanethidine, propanolol, methyldopa, or thyroid
medications.
Notes: Imipramine (63) + Placebo (61) = 124 participants.
Baseline: Alprazolam Imipramine Placebo Diazepam
HRSD-21 23.2 24.4 24.5 23.7
n= 259
Age: Mean 42
Sex: 114 males 145 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Patients with other psychiatric disorders, history
of convulsive disorder, significant uncontrolled medical
condiotions, individuals adversely affected by
benzodiazepines or tricyclics, and those who were abusing
street drugs and/or alcohol. Patients with conditions such as
glaucoma, urinary retention, or convulsive disorders.
Notes: Imipramine (64) + placebo (67) = 131 participants.
Baseline: Unknown.
n= 278
Age: Mean 44 Range 18-65
Sex: 152 males 126 females
Diagnosis:
100% Major depressive disorder by DSM-II
Exclusions: History or evidence of clinically significant renal
disease, BUN or creatinine elevations, hepatic disease,
SGOT, SGPT, or alkaline phosphatase elevations,
Data Used
Number reporting side effects
Leaving treatment early for any reason
Non-response 50% reduction in HRSD
HRSD-21 mean endpoint
Data Used
Non-response 50% reduction in HRSD
Leaving treatment early for any reason
Leaving treatment early due to side effects
Data Not Used
HRSD-21 mean endpoint - no data
Notes: Response rates correspond to patients
who completed at least 2 weeks' medication only.
Data Used
Non-response 50% reduction in HRSD
Leaving treatment early for any reason
Leaving treatment early due to side effects
HRSD-17 mean endpoint
Group
Group
Group
Group
Group
Group
1 N= 63
Imipramine. Mean dose 143mg/day -
Days 1-3: 75mg/day, and days 4-7:
100mg/day. Thereafter, dosages were
increased to 150mg/day unless side
effects prevented such an increase.
2 N= 61
Placebo. Mean dose 6.8 capsules/day -
Days 1-3: 3 capsules/day, and days 4-7: 4
capsules/day. Thereafter, dosage could
be increased to 6 capsules/day.
1 N= 64
Imipramine - 25-150mg/day by the end of
week 1.
2 N= 67
Placebo - No details.
1 N= 94
Placebo - No details.
2 N= 95
Amitriptyline - 75mg at start - could be
increased to 150mg/day at visit three.
Funding; unclear.
Funding; Upjohn company.
Funding; unknown.
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