TCAs versus placebo - National Center for Biotechnology Information

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FABRE1992 Study Type: RCT Study Description: 3-arm study; Paroxetine vs. Imipramine vs. Placebo Type of Analysis: ITT Blindness: Double blind Duration (days): Mean 42 Setting: Outpatients; US. Notes: 120 participants entered the study. 111 included in efficacy analyses. Info on Screening Process: Unknown. FABRE1996 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: Outpatients; US. Notes: F (46), I (48) and P (44) in ITT sample. Info on Screening Process: 235 participants screened; 150 entered (50 participants/group). FEIGER1996A Study Type: RCT Study Description: 3-arm study; Imipramine vs. Geripone vs. Placebo Type of Analysis: ITT; LOCF Blindness: Double blind Duration (days): Mean 56 Setting: Outpatients; US Info on Screening Process: Unknown. propranolol, a methyldopa or thyroid medications, or could not read of understand the symptoms check list. Notes: Imipramine (52) + Placebo (51) = 103 participants. Baseline: Unknown. n= 111 Age: Mean 36 Sex: 42 males 69 females Diagnosis: 100% Major depressive disorder by DSM-III Exclusions: Another primary psychiatric diagnosis, a history of alcohol or drug misuse within the previous 6 months, an unstable hepatic, renal, respiratory or cardiovascular disorder. History of glaucoma, urinary retention or a known allergy to imipramine. Pregnant or breastfeeding women. Women not currently using a medically acceptable form of contraception. Notes: Imipramine (37) + Placebo (36) = 73 participants. Imipramine (12M:25F) and Placebo (13M:23F). Baseline: Paroxetine Imipramine Placebo HAM-D (21) 29.7 (0.64) 27.8 (0.65) 28.8 (0.66) n= 150 Age: Sex: 33 males 105 females Diagnosis: 100% Major depressive disorder by DSM-III-R Exclusions: Any other primary psychiatric diagnosis, an unstable medical condition, clinically significant abnormal laboratory findings and patients who demonstrated a placebo response during the washout phase. Notes: Imipramine (48) + Placebo (44) = 92 participants. Imipramine (8M:40F) and Placebo (14M:30F) in ITT sample. Baseline: Fluvoxamine Imipramine Placebo HAM-D (21) 27.7 26.5 26.0 MADRS 30.6 30.6 29.5 n= 123 Age: Mean 40 Sex: 36 males 45 females Diagnosis: 100% Major depressive disorder by DSM-III-R Exclusions: Pregnant or lactating or sexually active and able to bear children but not using adequate methods of contraception. Axis I psychiatric diagnosis, delusions or hallucinations during the current episode of depression, high probability of needing other treatments during the course of the study, significant current medical conditions, meeting DSM-III-R criteria for psychoactive substance use disorder within the prior 12 months, allergy or hypersensitivity to azaperones or tricyclic antidepressants, significant suicide Data Used MADRS mean change HRSD-21 mean change Data Not Used Leaving treatment early for any reason - no data Notes: SDs for mean HRSD very small and gave high heterogeneity - convered to Ses and now no heterogeneity - assume error in labelling in the paper Data Used Number reporting side effects Leaving treatment early due to side effects Leaving treatment early for any reason Non-response 50% reduction in HRSD MADRS mean change HRSD-24 mean change Data Used Leaving treatment early for any reason Leaving treatment early due to side effects Number reporting side effects MADRS mean endpoint Data Not Used HRSD-21 mean endpoint - no data HRSD-17 mean endpoint - no data Notes: HAM-D 28 used where 21 denoted. Group Group Group Group Group Group 1 N= 37 Imipramine. Mean dose 135.2mg/day - Started at 80mg/day. Could be lowered to 65mg/day after the first week. The maximum dose could be increased to 275mg/day. 2 N= 36 Placebo - No details. 1 N= 48 Imipramine - 72-182 mg/day. Maximum dose 240mg/day. The initial dose was 40mg/day which was increased by 40mg/day every 3-4 days to a maximum dose of 240mg/day over a 3 week period as tolerated. Minimum dose of 80mg/day for those who could not tolerate max daily dose. 2 N= 44 Placebo - No details. 1 N= 41 Imipramine - Days 1-2: 50mg/day, days 3- 7: 100mg/day and 50-300mg/day thereafter. 2 N= 40 Placebo - Days 1-2: 1 capsule/day, days 3-7: 2 capsules/day and up to 6 capsules/day thereafter. Funding; unknown. Funding; pharma (Solvay Pharmaceuticals). Funding; unclear. 27
FEIGHNER1979 Study Type: RCT Study Description: 4-arm study; Amitriptyline vs. Limbitrol (Amitriptyline + Chlordiazepoxide) vs. Chlordiazepoxide vs. Placebo Type of Analysis: ITT; LOCF Blindness: Double blind Duration (days): Mean 28 Setting: Outpatients; multicentre, US. Notes: Randomisation was in blocks of 7 participants (2-2-2-1). 58 participants excluded from efficacy analysis. Info on Screening Process: Unknown. FEIGHNER1980 Study Type: RCT Study Description: 3-arm study; Imipramine vs. Trazodone vs. Placebo Type of Analysis: ITT Blindness: Double blind Duration (days): Mean 28 Setting: Inpatients; US Info on Screening Process: 50 participants admitted; 1 had pre-treatment HRSD
Page 1 and 2: Comparisons Included in this Clinic
Page 3 and 4: MERIDETH1983 NANDI1976 NORTON1984 P
Page 5 and 6: out in the first week. BEASLEY1991B
Page 7 and 8: Study Type: RCT Study Description:
Page 11: criteria either at screening or at
Page 17 and 18: Info on Screening Process: 765 part
Page 19 and 20: Blindness: Double blind Duration (d
Page 21 and 22: ITIL1983A Study Type: RCT Study Des
Page 27 and 28: Setting: Outpatients; US. Notes: 10
Page 31 and 32: RAMPELLO1991 Study Type: RCT Study
Page 33 and 34: unavailable for follow-up. known to
Page 39 and 40: episode. Baseline: Amitriptyline Mi
Page 41 and 42: DEBUS1980 Healthy participants DECA
Page 43 and 44: JOHNSTONE1980A Neurotic illness = n
Page 45 and 46: MULSANT2001B Irrelevant comparison
Page 47 and 48: ROTHBLUM1982 Combination therapy RO
Page 49 and 50: BEASLEY1991B (Published Data Only)
Page 51 and 52: FEIGHNER1989B (Published Data Only)
Page 53 and 54: LYDIARD1989 (Published Data Only) L
Page 55 and 56: SHRIVASTAVA1992 (Published Data Onl
Page 57 and 58: BALESTRIERI2004 Balestrieri, M., Ca
Page 59 and 60: CHANG2005 Chang, F. (2005). Strateg
Page 61 and 62: FINK1965 (Published Data Only) Fink
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HARRISON1986 (Published Data Only)
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KELLER1993 Keller, M. B., Lavori, P
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LEE1993 Lee, J. H., Reynolds, C. F.
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MULSANT2001B Mulsant, B. H., Sweet,
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PRESKORN1983 (Published Data Only)
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RICKELS1964 (Published Data Only) R
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SIRIS1987A (Published Data Only) Si
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VERSIANI1990A (Published Data Only)
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TCAs versus placebo - National Center for Biotechnology Information

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