TCAs versus placebo - National Center for Biotechnology Information

Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: 96 participants were volunteers with
symptoms of depression.
Info on Screening Process: Unknown.
RICKELS1982A
Study Type: RCT
Study Description: 3-arm study; Lofepramine
vs. Imipramine vs. Placebo
Type of Analysis: ITT?
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Info on Screening Process: Unknown.
RICKELS1982D
Study Type: RCT
Study Description: 3-arm study; Trazodone vs.
Amitriptyline vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: HRSD-21 scores all seem very small.
Bring up in discussion.
Info on Screening Process: Unknown.
RICKELS1985
Study Type: RCT
Study Description: 4-arm study; Alprazolam vs.
Doxepin vs. Amitriptyline vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; multicentre, US.
Notes: Participants had at least 2 weeks of
efficacy data.
Info on Screening Process: 605 screened; 101
excluded. Reasons; did not fulfill entry criteria,
wished to withdraw for nonmedical reasons, did
not cooperate with the physician or were
pregnant. Patients with schizophrenia, organic brain
syndrome, mental retardation, serious impairment of hepatic
or renal functions, or cardiovascular or metabolic disease
and those with known hypersensitivity to the study drugs.
Concomitant therapy with other psychotropic drugs, thyroid
medication, or anticholinergic agents was not permitted.
Notes: Imipramine (43) + Placebo (27) = 70 participants.
Baseline: HAM-D (21): 23.8
n= 158
Age: Mean 43 Range 30-56
Sex: 54 males 104 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Pregnant, lactatings, or planned to become
pregnant. Patients with schizophrenia, organic brain
syndrome, or mental retardation, as well as patients
suffering from serious impairment of hepatic or renal
functions, or cardiovascular or metabolic disease, and those
with known hypersensitivity to the study drugs. Concomitant
therapy with other psychotropic drugs was not permitted.
Notes: Depression: 54% endogenous and 46% reactive
subtype. Imipramine (52) + Placebo (52) = 104 participants.
Excluded participants who took less than 75mg/day of
imipramine from improvement analyses.
Baseline: HAM-D (21): 25.9 (5.7)
n= 202
Age: Mean 40
Sex: 69 males 133 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Unknown.
Notes: 45% endogenous depression. 55% reactive
subtype. Amitriptyline (68) + placebo (68) = 136 participants.
Baseline: HRSD (21): 1.26 (ALL)
n= 504
Age: Mean 39
Sex: 171 males 333 females
Diagnosis:
100% Major depressive disorder by Feighner
criteria
Exclusions: Patients who were psychopathic or psychotic,
patients with bipolar, involuational, schizoaffective
depression or suffering from secondary depression, patients
with severe liver or kidney disease, uncontrolled
cardiovascular, pulmonary, endocrinological, or collagen
diseases, glaucoma, or conditions in which use of TCAs is
contraindicated, including patients with a history of urinary
retention, paralytic ileus, and convulsive disorders. Patients
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
HRSD-21 mean endpoint
Data Used
Leaving treatment early for any reason
Number reporting side effects
HRSD-21 mean endpoint
Data Used
HRSD-21 mean endpoint
Leaving treatment early due to side effects
Leaving treatment early for any reason
Data Not Used
Non-response 50% reduction in HRSD - no
data
Group
Group
Group
Group
Group
Group
Group
2 N= 27
Placebo - Up to 8 capsules/day. Started
at 3 capsules/day in the first week.
1 N= 52
Imipramine - 105-210mg/day.
2 N= 52
Placebo - No details.
1 N= 68
Amitriptyline. Mean dose 123.75mg/day -
100mg/day by the end of week 1. Up to
200mg/day.
2 N= 68
Placebo. Mean dose 135mg/day - No
details.
1 N= 124
Amitriptyline. Mean dose 148mg/day -
50mg to start, increasing to 75mg/day by
day 3. From then on could increase to
225mg/day.
2 N= 130
Placebo - No details.
Funding; part-pharma (EM
Industries).
Funding; part-research.
Funding; unknown.
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