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Desvenlafaxine for the prevention of relapse in major depressive disorder: results of a randomized trial.
J Clin Psychopharmacol. 2010 Feb; 30(1):18-24.JC

Abstract

OBJECTIVES

To compare the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) with placebo in reducing relapse rate in patients with major depressive disorder (MDD).

METHODS

This phase 3, multicenter, randomized trial included a 12-week, open-label (OL) treatment phase (intent-to-treat population, n = 575) followed by a 6-month, double-blind (DB) relapse prevention phase. Patients who responded to the OL treatment (17-item Hamilton Rating Scale for Depression total score <or= 11) with desvenlafaxine (200-400 mg/d) were eligible to enter the DB phase. The primary efficacy end point was time until relapse (17-item Hamilton Rating Scale for Depression total score >or= 16 at any visit, Clinical Global Impression-Improvement score >or= 6 at any visit, or discontinuation due to unsatisfactory response).

RESULTS

Patients receiving desvenlafaxine (n = 189) experienced significantly longer times to relapse of MDD versus patients receiving placebo (n = 185) during the DB period (log-rank test, P < 0.0001). The percentages of patients relapsing were 42% (78/185) and 24% (45/189) for placebo and desvenlafaxine, respectively (P < 0.001). The most common primary reason cited for discontinuation in the OL period was adverse events (19%), which consisted of nausea, dizziness, and insomnia. A total of 159 patients (42%) discontinued treatment during the DB period, including 101 placebo- (55%) and 58 desvenlafaxine-treated patients (31%). The most frequent adverse event reported as reason for treatment discontinuation in the DB period was depression, reported by 14 placebo- (8%) and 7 desvenlafaxine-treated patients (4%).

CONCLUSIONS

Desvenlafaxine effectively prevented relapse of MDD during 6 months of DB treatment in patients who had responded to 12 weeks of OL desvenlafaxine therapy.

Authors+Show Affiliations

Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA. Krickels@mail.med.upenn.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20075643

Citation

Rickels, Karl, et al. "Desvenlafaxine for the Prevention of Relapse in Major Depressive Disorder: Results of a Randomized Trial." Journal of Clinical Psychopharmacology, vol. 30, no. 1, 2010, pp. 18-24.
Rickels K, Montgomery SA, Tourian KA, et al. Desvenlafaxine for the prevention of relapse in major depressive disorder: results of a randomized trial. J Clin Psychopharmacol. 2010;30(1):18-24.
Rickels, K., Montgomery, S. A., Tourian, K. A., Guelfi, J. D., Pitrosky, B., Padmanabhan, S. K., Germain, J. M., Leurent, C., & Brisard, C. (2010). Desvenlafaxine for the prevention of relapse in major depressive disorder: results of a randomized trial. Journal of Clinical Psychopharmacology, 30(1), 18-24. https://doi.org/10.1097/JCP.0b013e3181c94c4d
Rickels K, et al. Desvenlafaxine for the Prevention of Relapse in Major Depressive Disorder: Results of a Randomized Trial. J Clin Psychopharmacol. 2010;30(1):18-24. PubMed PMID: 20075643.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Desvenlafaxine for the prevention of relapse in major depressive disorder: results of a randomized trial. AU - Rickels,Karl, AU - Montgomery,Stuart A, AU - Tourian,Karen A, AU - Guelfi,Julien D, AU - Pitrosky,Bruno, AU - Padmanabhan,Sudharshan Krishna, AU - Germain,Jean-Michael, AU - Leurent,Claire, AU - Brisard,Claudine, PY - 2010/1/16/entrez PY - 2010/1/16/pubmed PY - 2010/3/20/medline SP - 18 EP - 24 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 30 IS - 1 N2 - OBJECTIVES: To compare the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) with placebo in reducing relapse rate in patients with major depressive disorder (MDD). METHODS: This phase 3, multicenter, randomized trial included a 12-week, open-label (OL) treatment phase (intent-to-treat population, n = 575) followed by a 6-month, double-blind (DB) relapse prevention phase. Patients who responded to the OL treatment (17-item Hamilton Rating Scale for Depression total score <or= 11) with desvenlafaxine (200-400 mg/d) were eligible to enter the DB phase. The primary efficacy end point was time until relapse (17-item Hamilton Rating Scale for Depression total score >or= 16 at any visit, Clinical Global Impression-Improvement score >or= 6 at any visit, or discontinuation due to unsatisfactory response). RESULTS: Patients receiving desvenlafaxine (n = 189) experienced significantly longer times to relapse of MDD versus patients receiving placebo (n = 185) during the DB period (log-rank test, P < 0.0001). The percentages of patients relapsing were 42% (78/185) and 24% (45/189) for placebo and desvenlafaxine, respectively (P < 0.001). The most common primary reason cited for discontinuation in the OL period was adverse events (19%), which consisted of nausea, dizziness, and insomnia. A total of 159 patients (42%) discontinued treatment during the DB period, including 101 placebo- (55%) and 58 desvenlafaxine-treated patients (31%). The most frequent adverse event reported as reason for treatment discontinuation in the DB period was depression, reported by 14 placebo- (8%) and 7 desvenlafaxine-treated patients (4%). CONCLUSIONS: Desvenlafaxine effectively prevented relapse of MDD during 6 months of DB treatment in patients who had responded to 12 weeks of OL desvenlafaxine therapy. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/20075643/Desvenlafaxine_for_the_prevention_of_relapse_in_major_depressive_disorder:_results_of_a_randomized_trial_ L2 - http://dx.doi.org/10.1097/JCP.0b013e3181c94c4d DB - PRIME DP - Unbound Medicine ER -