A Randomized, Placebo-Controlled Trial of Sertraline for Prophylactic Treatment of Highly Recurrent Major Depressive Disorder
Abstract
OBJECTIVE: Previous antidepressant maintenance trials have used the same medication from acute through maintenance phases, confounding the interpretation of prophylactic effects. The purpose of this study was to determine whether sertraline prevents the recurrence of major depressive disorder among patients with recurrent depression who had been treated to remission with medications other than sertraline. METHOD: Patients who had experienced at least three documented episodes of major depressive disorder within the last 4 years and who were currently in full remission were eligible. The last episode must have been treated for at least 4 months with any antidepressant except sertraline. For the initial single-blind placebo lead-in phase, 371 patients were included; 288 were included in the analyses for the 18-month double-blind phase in which patients were randomly assigned to sertraline (50 or 100 mg) or placebo (two capsules per day). Recurrence was defined as a depressive episode that fulfilled DSM-IV criteria or the appearance of symptoms that required the administration of another antidepressant treatment. RESULTS: Sixty-one patients discontinued before the double-blind phase, including 33 who experienced a relapse. Out of the 288 who entered the double-blind prophylactic phase, 123 discontinued, including 65 for recurrences. Recurrences were significantly lower in the sertraline groups compared with placebo (sertraline, 50 mg: 16 [16.8%] of 95; sertraline, 100 mg: 16 [17.0%] of 94; placebo: 33 [33.3%] of 99). Patients treated with sertraline also had a significantly longer time until recurrence compared with placebo-treated patients. CONCLUSIONS: Among remitted patients with a history of multiple depressive episodes, sertraline at a dose of either 50 or 100 mg/day prevented recurrences significantly more than did placebo.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Treatment effects appeared to be superior among patients with multiple (especially ≥3) previous episodes of depression.
“Several of the studies reviewed found that treatment effects appeared to be superior among patients with multiple (especially ≥3) previous episodes of depression (Montgomery et al., 1993; Teasdale et al., 2000; Lepine et al., 2004; Ma and Teasdale, 2004; Kelin et al., 2010).”
From Prevention of Relapse and Recurrence in Adults with Major Depressive Disorder: Systematic Review and Meta-Analyses of Controlled Trials (2016) · cites this paper as Lepine et al., 2004
Cites
Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study
Murray, C. J., & Lopez, A. D. (1997) · The Lancet · doi:10.1016/s0140-6736(96)07495-8 · Cited by 4,492 · see citing works
Frank, E. (1991) · Archives of General Psychiatry · doi:10.1001/archpsyc.1991.01810330075011 · Cited by 1,959 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Cleare, A., Pariante, C., Young, A., Anderson, I., Christmas, D., Cowen, P., Dickens, C., Ferrier, I., Geddes, J., Gilbody, S., et al. (2015) · Journal of Psychopharmacology · doi:10.1177/0269881115581093 · Cited by 759 · see citing works
Maintenance Treatment of Major Depression in Old Age
Reynolds, C. F., Dew, M. A., Pollock, B. G., Mulsant, B. H., Frank, E., Miller, M. D., Houck, P. R., Mazumdar, S., Butters, M. A., Stack, J. A., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa052619 · Cited by 476 · see citing works
Sim, K., Lau, W. K., Sim, J., Sum, M. Y., & Baldessarini, R. J. (2016) · International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyv076 · Cited by 218 · see citing works
“, 2005, 2009) than with pharmacotherapies (Montgomery and Dunbar, 1993; M Fava et al., 1998; Lepine et al., 2004; Keller et al., 2007a; 2007b; Kocsis et al., 2007; Kuyken et al., 2008; Bondolfi et al., 2010; Kelin et al., 2010; Mathew et al., 2010; Thase et al., 2011).”
BackgroundBauer, M., Severus, E., Köhler, S., Whybrow, P. C., Angst, J., Möller, H.-J., & on behalf of the Wfsbp Task Force on Treatment Guidelines for Unipolar Depressive Disorders (2015) · The World Journal of Biological Psychiatry · doi:10.3109/15622975.2014.1001786 · Cited by 199 · see citing works
Hansen, R., Gaynes, B., Thieda, P., Gartlehner, G., Deveaugh-Geiss, A., Krebs, E., & Lohr, K. (2008) · Psychiatric Services · doi:10.1176/ps.2008.59.10.1121 · Cited by 172 · see citing works
Kaymaz, N., van Os, J., Loonen, A. J. M., & Nolan, W. A. (2008) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v69n0910 · Cited by 135 · see citing works
Braun, C., Bschor, T., Franklin, J., & Baethge, C. (2016) · Psychotherapy and Psychosomatics · doi:10.1159/000442293 · Cited by 103 · see citing works
Van Leeuwen, E., van Driel, M. L., Horowitz, M. A., Kendrick, T., Donald, M., De Sutter, A. I., Robertson, L., & Christiaens, T. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013495.pub2 · Cited by 90 · see citing works
Preventing Relapse and Recurrence of Depression:<i>A Brief Review of Therapeutic Options</i>
Thase, M. E. (2006) · CNS Spectrums · doi:10.1017/s1092852900015212 · Cited by 93 · see citing works
Relapse rates with long‐term antidepressant drug therapy: a meta‐analysis
Williams, N., Simpson, A. N., Simpson, K., & Nahas, Z. (2009) · Human Psychopharmacology: Clinical and Experimental · doi:10.1002/hup.1033 · Cited by 74 · see citing works
The pharmacological management of depression
Kupfer, D. J. (2005) · Dialogues in Clinical Neuroscience · doi:10.31887/dcns.2005.7.3/dkupfer · Cited by 69 · see citing works
Kocsis, J. H., Thase, M. E., Trivedi, M. H., Shelton, R. C., Kornstein, S. G., Nemeroff, C. B., Friedman, E. S., Gelenberg, A. J., Dunner, D. L., Hirschfeld, R. M. A., et al. (2007) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v68n0706 · Cited by 67 · see citing works
Kornstein, S. G., Bose, A., Li, D., Saikali, K. G., & Gandhi, C. (2006) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v67n1115 · Cited by 60 · see citing works
Studies of Long-Term Use of Antidepressants: How Should the Data from Them be Interpreted?
El-Mallakh, R. S., & Briscoe, B. (2012) · CNS Drugs · doi:10.2165/11599450-000000000-00000 · Cited by 36 · see citing works
Safer, D. J. (2016) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000564 · Cited by 19 · see citing works
Licht, R. W. (2013) · Journal of Affective Disorders · doi:10.1016/j.jad.2012.12.009 · Cited by 11 · see citing works
- Authors
- Lépine, J.-P., Caillard, V., Bisserbe, J.-C., Troy, S., Hotton, J.-M., Boyer, P., & For the PREVERS Investigators
- Affiliations
- Assistance Publique – Hôpitaux de Paris (FR)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Venue
- American Journal of Psychiatry
- Published
- 2004-05-01
- Volume
- 161
- Issue
- 5
- Pages
- 836-842
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2161052210
- Cited by
- 83
- References
- 2
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2021: 1 · 2019: 2 · 2017: 4 · 2016: 5 · 2015: 4 · 2014: 2 · 2013: 4 · 2012: 2
- FWCI
- 4.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- sertraline, depression recurrence prevention, major depressive disorder, recurrent depression, antidepressant prophylaxis, maintenance therapy, remission, selective serotonin reuptake inhibitors
- MeSH terms
- Adult, Clinical Protocols, Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Placebos, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Sertraline, Secondary Prevention
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
