TCAs versus placebo - National Center for Biotechnology Information

Study Type: RCT
Study Description: 3-arm study; Nefazodone vs.
Imipramine vs. Placebo
Type of Analysis: ITT; LOCF
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US
Info on Screening Process: Unknown.
FEIGHNER1989A
Study Type: RCT
Study Description: 3-arm study; Paroxetine vs.
Imipramine vs. Placebo.
Type of Analysis: Completers (at least 4 days of
treatment)
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US
Info on Screening Process: Unknown.
FEIGHNER1989B
Study Type: RCT
Study Description: 3-arm study; Fluvoxamine
vs. Imipramine vs. Placebo
Type of Analysis: ITT
Blindness: Double blind
Duration (days): Mean 42
Setting: Inpatients; US.
Notes: After 2 weeks on study drug the patient
could be discharged if sufficiently improved and
followed as an outpatient for the remainder of
the trial.
Info on Screening Process: Unknown.
FEIGHNER1989C
Study Type: RCT
Study Description: 3-arm study; Imipramine vs.
Fluoxetine vs. Placebo
Type of Analysis: Completers
Blindness: Double blind
Duration (days): Mean 42
Setting: Outpatients; US.
Notes: 145 participants completed at least 2
n= 45
Age: Mean 45 Range 27-64
Sex: 23 males 22 females
Diagnosis:
100% Depression by RDC
Exclusions: Unknown.
Notes: Imipramine (15) + Placebo (15) = 30 participants.
Imipramine (7M:8F) and Placebo (8M:7F). Participants met
RDC Endogenous Major Depression and DSM III Major
Depression with Melancholia.
Baseline: Unknown.
n= 120
Age:
Sex:
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Patients were excluded if they posed a serious
suicidal risk, had a primary psychiatric diagnosis other than
depression, a history of alcohol or other substance misuse
within the past six months, were pregnant or breast feeding,
had clinically significant laboratory findings, or a medical
contraindication to imipramine such as a history of seizures,
urinary retention, or glaucoma.
Notes: Imipramine (40) + Placebo (37) = 77 participants.
Baseline: Unknown.
n= 86
Age: Mean 41 Range 18-71
Sex: 13 males 73 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Unknown.
Notes: Imipramine (36) + Placebo (19) = 55 participants.
Imipramine (32F:4M) and Placebo (17F:2M).
Baseline: Unknown.
n= 145
Age: Mean 42
Sex: 37 males 108 females
Diagnosis:
100% Major depressive disorder by DSM-III
Exclusions: Pregnant, not practicing medically acceptable
contraception, or if they posed a serious suicide risk.
Organic brain syndrome, schizophrenia, a history of
Data Used
Leaving treatment early for any reason
Data Not Used
Leaving treatment early due to side effects
HRSD-17 mean endpoint - no data
Data Used
Leaving treatment early due to side effects
Leaving treatment early for any reason
Non-response 50% reduction in HRSD - no
data
Data Not Used
MADRS mean endpoint - no data
Data Used
Leaving treatment early due to side effects
Data Used
HRSD-21 mean endpoint
Leaving treatment early for any reason
Leaving treatment early due to side effects
Group
Group
Group
Group
Group
Group
Group
Group
1 N= 15
Imipramine. Mean dose 135.2mg.day -
Started at 50mg/day. This could be
increased by up to 50mg/day to a
maximum of 250mg/day. This could be
decreased in the event of side effects.
2 N= 15
Placebo - Started at 2 capsules/day.
1 N= 40
Imipramine - Maximum dose: 275mg/day.
2 N= 37
Placebo - No details.
1 N= 36
Imipramine - 150-300mg/day.
2 N= 19
Placebo - No details.
1 N= 45
Imipramine - Maximum dose: 150mg/day.
2 N= 48
Placebo - No details.
Funding; unknown.
Funding; unknown.
Funding; unclear.
Funding; unclear.
30