TCAs versus placebo - National Center for Biotechnology Information

MARCH1990
Study Type: RCT
Study Description: 3-arm study; Fluvoxamine
vs. Imipramine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US
Notes: 54 participants entered study. 40
completed.
Info on Screening Process: Unknown.
MARKOWITZ1985
Study Type: RCT
Study Description: 3-arm study; Phenelzine vs.
Imipramine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Unclear; US.
Info on Screening Process: Unknown.
MENDELS1986
Study Type: RCT
Study Description: 3-arm study; Alprazolam vs.
Imipramine vs. Placebo
Type of Analysis: ITT: LOCF (at least 1 week of
treatment)
Blindness: Double blind
Duration (days): Mean 42
significant laboratory or ECG abnormalities.
Notes: Amitriptyline (131) + Placebo (129) = 260
participants. Amitriptyline (90F:41M) and Placebo
(86F:43M). MDD Single = 128 participants. MDD Recurrent
= 264 participants.
Baseline: Amitriptyline Sertraline Placebo (Note:
SE in brackets)
HAM-D 22.1 (0.26) 21.5 (0.24) 22.1 (0.25)
BDI 15.0 (0.56) 14.6 (0.56) 14.3 (0.57)
n= 54
Age: Mean 39
Sex: 17 males 37 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Pregnant women, lactating women, women of
childbearing potential who were taking inadequate
contraceptive measures, patients with schizophrenia,
psychotic symptoms, organic dementias, or a diagnosis
within 1 year of substance misuse or alcoholism, patients
with cardiovascular, hepatic, renal, gastrointestinal,
pulmonary, metabolic, or other systemic diseases that could
interfere with the diagnosis, treatment, or assessment of
depression, patients who required treatment with any
concurrent medication that might interact with or obscure the
action of the study medications, patients with clinically
significant abnormalities in electrocardiographic or laboratory
results, patients with multiple drug allergies, patients who
had received monoamine oxidase inhibitors or lithium in the
2 weeks preceding study entry or who had received any
other antidepressant drugs in the preceding 1 week, and
patients who had received any investigational drug or ECT in
the previous 4 weeks.
Notes: Imipramine (15) + Placebo (12) = 27 participants.
Baseline: Unknown.
n= 238
Age:
Sex:
Diagnosis:
100% Depression by DSM-III
Exclusions: Unknown.
Notes: Imipramine (80) + Placebo (77) = 157 participants.
Baseline: Unknown.
n= 98
Age: Mean 37
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Data Not Used
MADRS mean endpoint - no data
HRSD-17 mean endpoint - no data
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Data Used
Leaving treatment early for any reason
Leaving treatment early due to side effects
Non-response 50% reduction in HRSD
Data Not Used
HRSD-17 mean endpoint - no data
Group
Group
Group
Group
Group
1 N= 15
Imipramine - Days 1-3: 50 mg/day, days 4-
7: 100mg/day, days 8-14: 150mg/day.
After day 14, dose could be increased to
a maximum of 300mg/day depending on
clinical response.
2 N= 12
Placebo - Days 1-3: 1 capsule/day, days
4-7: 2 capsules/day, days 8-14: 3
capsules/day and from thereon up to 6
capsules a day depending on clinical
response.
1 N= 80
Imipramine - At least 200mg.
2 N= 77
Placebo - No details.
1 N= 34
Imipramine. Mean dose 167mg/day - No
details.
Funding; part-pharma (Kali-
Duphar Laboratories).
Funding; unknown.
Funding; unknown.
Sex: 53 males 45 females
Diagnosis:
100% Major depressive disorder by No details
Group 2 N= 34
Placebo. Mean dose 3.7 capsules/day -
No details.
41
Exclusions: Pregnant women and those who could become