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A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression
Abstract
This study compared the efficacy and safety of the selective serotonin reuptake inhibitor sertraline with that of the tricyclic antidepressant clomipramine in patients with severe depression, as defined by a baseline 17-item Hamilton Depression Rating Scale (HAM-D) of at least 25. The study included 166 outpatients, randomized to double-blind treatment with sertraline (50-200 mg) or clomipramine (50-150 mg) for 8 weeks. The efficacy of both treatments was similar, 74% of patients in the sertraline group and 71% of clomipramine patients being classified as responders at the end-point, as defined by a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2. Mean HAM-D scores fell from 29.8 at baseline to 12.3 at endpoint in the sertraline group, and from 29.6-12.7 in the clomipramine group. There were more withdrawals due to adverse events in the clomipramine group than in the sertraline group (17% versus 12%). Dry mouth, tremor, dizziness and constipation were all substantially more common in the clomipramine group, whereas diarrhoea/loose stools was more common in the sertraline group. Overall, sertraline was as effective as clomipramine in this group of severely depressed outpatients, and showed better tolerability.
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There were no differences between clomipramine (50-150mg) and sertraline (50-200mg) on LSEQ and HAMD sleep scores, but both showed significant improvements on all four LSEQ factors.
“(Lepine et al., 2000) demonstrated no differences between clomipramine (50-150mg) and sertraline (50-200mg) on LSEQ and HAMD sleep scores, but both showed significant improvements on all four LSEQ factors (Ease of getting to sleep (EGS); perceived quality of sleep (QOS); ease of awakening (EOA); and behaviour following wakefulness (BFW)).”
From Antidepressants and their effect on sleep (2005) · cites this paper as Lepine et al., 2000
Sertraline (50-200mg) and clomipramine (50-150mg) significantly improved LSEQ (all factors) and HAMD sleep scores, but there were no between-group differences.
“(Lepine et al., 2000) showed that sertraline (50-200mg) and clomipramine (50-150mg) significantly improved LSEQ (all factors) and HAMD sleep scores, but there were no between-group differences.”
From Antidepressants and their effect on sleep (2005) · cites this paper as Lepine et al., 2000
Clinician ratings of sleep (via HAMDS) have improved with amitriptyline, clomipramine, imipramine, dothiepin and doxepin.
“Clinician ratings of sleep (via HAMDS) have improved with amitriptyline (Versiani et al., 1999), clomipramine (Lepine et al., 2000), imipramine (Rosenberg et al., 1994), dothiepin (Corne and Hall, 1989) and doxepin (Feighner et al., 1986).”
From Antidepressants and their effect on sleep (2005) · cites this paper as Lepine et al., 2000
Improved subjective ratings of sleep have been reported with amitriptyline, clomipramine, imipramine and doxepin.
“Improved subjective ratings of sleep have been reported with amitriptyline (De Ronchi et al., 1998), clomipramine (Lepine et al., 2000), imipramine (Ware et al., 1989) and doxepin (Hajak et al., 2001).”
From Antidepressants and their effect on sleep (2005) · cites this paper as Lepine et al., 2000
Clinician-rated HAMDS scores were improved in trials that investigated citalopram, sertraline, fluoxetine, fluvoxamine and paroxetine.
“Clinician-rated HAMDS scores were improved in the trials that investigated citalopram (Mendels et al., 1999), sertraline (Lepine et al., 2000), fluoxetine (Winokur et al., 2003), fluvoxamine (Dalery and Honig, 2003) and paroxetine (Dunbar et al., 1993).”
From Antidepressants and their effect on sleep (2005) · cites this paper as Lepine et al., 2000
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Antidepressants and their effect on sleep
Mayers, A. G., & Baldwin, D. S. (2005) · Human Psychopharmacology: Clinical and Experimental · doi:10.1002/hup.726 · Cited by 323
Bahji, A., Ermacora, D., Stephenson, C., Hawken, E. R., & Vazquez, G. (2020) · Journal of Affective Disorders · doi:10.1016/j.jad.2020.03.030 · Cited by 139
Metadata
- Authors
- Lépine, J. P., Goger, J., Blashko, C., Probst, C., Moles, M.-F., Kosolowski, J., Scharfetter, B., & Lane, R. M.
- Affiliations
- Hôpital Fernand-Widal (FR)
- Centracare (CA)
- Pfizer (United States) (US)
- Corresponding author
- Lane, R. M.
- Venue
- International Clinical Psychopharmacology
- Published
- 2000-09
- Volume
- 15
- Issue
- 5
- Pages
- 263-271
- ISSN
- 0268-1315 (ISSN-L)
- OpenAlex
- W2000541904
- Cited by
- 19
- References
- 0
- Citations by year
- 2020: 1 · 2019: 1 · 2012: 1
- FWCI
- 0.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Disorders
- Keywords
- sertraline, clomipramine, major depressive disorder, severe depression, outpatients, selective serotonin reuptake inhibitors, tricyclic antidepressants, antidepressant efficacy, drug tolerability, adverse events, xerostomia, constipation, diarrhea, tremor
- MeSH terms
- Adult, Aged, Antidepressive Agents, Antidepressive Agents, Tricyclic, Clomipramine, Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Outpatients, Severity of Illness Index, Sleep, Treatment Outcome, Sertraline
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