Switching to duloxetine from selective serotonin reuptake inhibitor antidepressants: a multicenter trial comparing 2 switching techniques.
ABSTRACT To compare 2 methods of switching selective serotonin reuptake inhibitor (SSRI) non-responders or partial responders to duloxetine.
Adult outpatients with DSM-IV major depressive disorder, a Hamilton Rating Scale for Depression (HAM-D(17)) total score of >or= 15, and a Clinical Global Impressions-Severity of Illness score of >or= 3 despite at least 6 weeks of SSRI treatment were randomly assigned to either abrupt discontinuation of SSRI immediately followed by initiation of duloxetine (direct switch [DS]; N = 183) or tapered discontinuation of SSRI over 2 weeks and simultaneous administration of duloxetine (start-taper switch [STS]; N = 185). Efficacy, safety, and tolerability outcomes associated with these 2 switch methods were compared following switch and after 10 weeks of duloxetine treatment. The study was conducted from August 2004 to March 2006.
There was a significant improvement in depressive symptom severity in both switch groups as measured by mean change in HAM-D(17) total score (p <or= .001), but no difference between the switch groups (-10.23 DS vs. -10.49 STS). Criteria for noninferiority of the DS group to the STS group, which was the primary objective of the study, were met. Response rates (54.4% DS vs. 59.6% STS), remission rates (35.7% DS vs. 37.2% STS), and other secondary outcome measures were similar for both switch groups. Few patients discontinued the study due to adverse events (6.6% DS vs. 3.8% STS). Headache, dry mouth, and nausea were the most frequently reported adverse events in both switch groups.
Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used.
clinicaltrials.gov Identifier: NCT00191932.
- SourceAvailable from: Luca Lavagnino[Show abstract] [Hide abstract]
ABSTRACT: Attempts have been made to find appropriate drug regimens to treat binge eating disorder (BED). Several reports have examined the use of selective serotonin reuptake inhibitors (SSRIs) or mood stabilizers; both serotonin and noradrenalin reuptake inhibitors (SNRIs) have been reported to be useful for binge eating, but the available data are limited. We evaluated the efficacy of duloxetine, an SNRI, in 45 obese patients who reported binge eating. Forty-five patients with BED or binge eating with sub-threshold symptoms (s-BED) with high eating impulsivity, received duloxetine 60-120 mg/day for 12 weeks. A significant reduction in number of binges/week was observed in BED patients; statistical analyses performed on the whole sample revealed significant reductions in scores on the binge eating scale (BES) and the Beck depression inventory (BDI), weight, body mass index (BMI), clinical global impression, and the bulimia scale of the eating disorder inventory-2. The reduction in BES and BDI scores was not statistically different between BED and s-BED subjects. Although preliminary, results from this open trial suggest that duloxetine may be a successful option to reduce binge eating and depressive symptoms in both obese BED and s-BED outpatients.Human Psychopharmacology Clinical and Experimental 08/2009; 24(6):483-8. DOI:10.1002/hup.1040 · 1.85 Impact Factor
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ABSTRACT: Objectives. To evaluate the efficacy and safety of switching from a selective serotonin reuptake inhibitor (SSRI) to duloxetine in non-or partial responders. Methods. This is a post-hoc analysis of the pooled data of the Spanish sample from an open-label, multicentre study. Additionally, a 6-month continuation safety phase was performed. Results. A total of 156 patients were switched to duloxetine from SSRIs. More than 83% completed the acute phase, of whom 75% went into the continuation phase. At baseline, the mean duration of SSRI treatment was 71.2 weeks and the HAM-D 17 mean score was 22.4. In the acute-phase, symptoms severity significantly improved after 10 weeks of duloxetine treatment as measured by mean change from baseline in HAM-D 17 total score ((10.5; P B0.001) and all secondary efficacy measures, including painful symptoms. Response (]50% decrease in HAM-D 17 total score) and remission rates (HAM-D 17 total score57) were 52.9 and 27.7%, respectively. The most common adverse events reported in both phases were headache (11.5% [acute]; 6.1% [continuation]) and nausea (6.4% [acute]; 5.1% [continuation]). Conclusions. In a population of Spanish SSRI non-and partial responders, switch to duloxetine was associated with significant improvement in emotional and painful symptoms of depression. Duloxetine was well tolerated and safe during both phases.International Journal of Psychiatry in Clinical Practice 01/2009; 13(2):100-108. DOI:10.1080/13651500802578975 · 1.31 Impact Factor
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ABSTRACT: Painful physical symptoms (PPS) are common in patients with depression. Our objective was to evaluate the presence of PPS in a sample of SSRI non- or partial-responders with MDD and examine the effect of a switch to duloxetine on those PPS. Outpatients who met criteria for MDD despite having taken an SSRI antidepressant for at least 6 weeks, and who had a Hamilton depression rating scale total score of at least 15 and a clinical global impression of severity score of at least 3, were randomized to switch to duloxetine by either a direct switch or a start-taper switch method. PPS were assessed at baseline and at the study endpoint using various measures including six visual analog scales (VAS) for pain (overall pain, headache, back pain, shoulder pain, interference with daily activities, and time in pain while awake), the pain subscale of the symptom questionnaire-somatic subscale, and the bodily pain subscale of the short form-36 item health survey. Clinically significant levels of pain (mean baseline VAS scores >30 mm) were seen across all VAS pain measures prior to switching. Switch to duloxetine was associated with significant improvements on all pain measures regardless of switch method, and there was evidence for an earlier reduction in pain in the start-taper switch group. In summary, MDD patients who were non- or partial-responders to SSRI treatment were found to have clinically significant pain which improved significantly following switch to duloxetine regardless of the switch method utilized.Journal of Psychiatric Research 08/2008; 43(5):512-8. DOI:10.1016/j.jpsychires.2008.07.001 · 4.09 Impact Factor