TCAs versus placebo - National Center for Biotechnology Information

Study Type: RCT
Study Description: 3-arm study; Tyrosine vs.
Imipramine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 28
Setting: Outpatients; US
Info on Screening Process: Unknown.
GEORGOTAS1982A
Study Type: RCT
Study Description: 3-arm study; Zimeldine vs.
Amitriptyline vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 28
Setting: Unclear; US.
Notes: 60 participants completed at least 2
weeks' treatment. Assumed 20 participants per
treatment arm.
Info on Screening Process: Unknown.
GEORGOTAS1986A
Study Type: RCT
Study Description: 3-arm study; Nortriptyline vs.
Phenelzine vs. Placebo
Type of Analysis: Unclear
Blindness: Double blind
Duration (days): Mean 49
Setting: Outpatients; US.
Notes: RANDOMISATION: randomised, no
details
Info on Screening Process: 295 screened; 137
met inclusion criteria; 126 entered washout
period; 90 in double-blind study
GERNER1980B
Study Type: RCT
Study Description: 3-arm study; Trazodone vs.
Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
n= 65
Age: Mean 40 Range 21-60
Sex: 46 males 19 females
Diagnosis:
100% Major depressive disorder by RDC
Exclusions: History of mania, symptoms of psychosis or a
diagnosis of schizophrenia, those unable to give informed
consent, or patients with a current diagnosis of alcoholism,
other drug addiction, epilepsy or clinical evidence of serious
suicidal risk with poor past response to antidepressant
therapy or with medical illnesses that might interfere with
treatment.
Notes: Imipramine (22) + Placebo (22) = 44 participants.
Imipramine (16M:6F) and Placebo (14M:8F).
Baseline: Tyrosine Imipramine Placebo
HAMD (21) 24.3 24.3 24.5
n= 52
Age: Mean 40
Sex: 31 males 21 females
Diagnosis:
100% Major depressive disorder by RDC
Exclusions: Intercurrent medical illness, childbearing
potential, and the need to take other medications.
Notes: AMI (15) + PLA (18) = 33 participants. Amitriptyline
(12M:3F) and Placebo (10M:8F).
Baseline: Zimelidine Amitriptyline Placebo
HAM-D 21 (SE) 29.9 (1.1) 28.5 (1.5) 28.6 (1.3)
n= 58
Age: Mean 65 Range 55-76
Sex: 22 males 36 females
Diagnosis:
100% Major depressive disorder by RDC
Exclusions: HAMD-21 < 16; moderate or severe dementia;
drug/alcohol dependence; mental retardation; serious
neurological disorders; other pre-existing major psychiatric
disorders; serious medical illness; urinary retention; narrowangle
glaucoma; supersensitivity to TCAs or MAOIs.
Notes: Ns do not include phenelzine group; No M/F based
on % M/F in ITT sample
Baseline: Placebo Nortriptyline Phenelzine
HAM-D 21 23.07 23.58 22.14
n= 60
Age: Mean 68 Range 60-90
Sex: 23 males 37 females
Diagnosis:
100% Depression by RDC
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Data Used
Leaving treatment early for any reason
BDI mean endpoint
HRSD-21 mean endpoint
Data Used
Non-remission HRSD-21 < 10
Number reporting side effects
Leaving treatment early for any reason
Data Not Used
HRSD-21 mean endpoint - no variablility
measure
Notes: Remission reported as 'response' but
definition closer to that for remission on other
studies
Data Used
Non-remission HRSD-17 < 10
Non-response 50% reduction in HRSD
Leaving treatment early for any reason
Data Not Used
HRSD-17 mean endpoint - no data
Group
Group
Group
Group
Group
Group
Group
Group
1 N= 22
Imipramine - 2.5mg/kg/day. By study day
9 participants were to achieve a target
dose of 2.5mg/kg/day in three divided
doses. They were to take this for 4 weeks.
2 N= 22
Placebo - No details.
1 N= 18
Placebo. Mean dose 223mg/day - No
details.
2 N= 15
Amitriptyline. Mean dose 206mg/day -
150mg/day by the end of week 1 and
300mg/day by the end of week 2.
1 N= 28
Nortriptyline. Mean dose 79 mg/day - 1-3:
25mg/day, then days 4-7: 50mg/day. At
then end of the first week, the daily dose
was increased to 75mg/day. Patients who
attained a plasma level between 50-
180ng/ml at the end of week 2 remained
on 75mg/day. Otherwise, patients took up
to 125mg/day.
2 N= 30
Placebo - Days 1-3: 1 capsules/day, then
days 4-7: 2 capsules/day. At then end of
the first week of treatment, the daily dose
was increased to 3 capsules/day.
1 N= 20
Imipramine. Mean dose 145mg/day - 50-
200mg/day.
2 N= 20
Placebo - Equivalent of 50-200mg/day.
Funding; unclear.
Funding; unknown.
SIGN 1+; funding partly
NIMH grant, no further
details
Funding; part-pharma (Mead
Johnson Pharmaceuticals).
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