Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo‐controlled clinical trials

Hudson, James I.; Wohlreich, Madelaine M.; Kajdasz, Daniel K.; Mallinckrodt, Craig; Watkin, John G.; Martynov, Oleg

doi:10.1002/hup.696

Cited by 108 publications

(93 citation statements)

References 43 publications

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“…38 Overall, 9.7% (vs 4.2% of placebo group) of patients in the RCTs discontinued duloxetine because of TEAEs. While these data cannot be directly compared to the FMS trials because of different patient populations, study designs and durations, similar rates of discontinuation were seen in the three duloxetine FMS RCTs.…”

Section: Safety and Tolerability Of Duloxetinementioning

confidence: 96%

“…37 Also, FIBRO symptoms such as Fatigue and Insomnia were not studied despite both fatigue and insomnia being frequently reported treatment-emergent adverse events (TEAEs) with duloxetine use in patients with MDD. 38 A later 12-week duloxetine RCT studying the effect of duloxetine treatment in 354 female FMS patients with and without MDD addressed the limitations of the first study and provided more clinically applicable conclusions. 26 As with the first trial, the majority of patients were Caucasian (89.5%), with 8.2% classified as 'Hispanic' and 2% being of 'African descent.'…”

Section: Dovepressmentioning

confidence: 99%

“…38 On average, patients initially lose 0.46 kg but typically return to baseline weight 12 weeks after initiation of duloxetine followed by weight gain. Weight gain is dose dependent, with the percentage of patients gaining 7% of baseline bodyweight numbering 3.1% on placebo, 8.6% on duloxetine 60 mg/day, and 12.8% on 120 mg/day.…”

Section: Safety and Tolerability Of Duloxetinementioning

confidence: 99%

“…Average time to onset for nausea is typically within one day of treatment with a time to resolution averaging seven days in the MDD trials. 38 As fatigue and sleep disturbance are often significant problems for FMS patients in addition to pain, the side effect profile of duloxetine raises concerns about use in these FMS patients. Sleep disturbance and fatigue trended toward, but did not reach, statistical significance in the Russell et al study, 27 and a dose-response relationship with somnolence symptoms was seen in duloxetine-treated patients in the second FMS RCT that reached statistical significance in the highest dosage group (60 mg twice daily).…”

Section: Safety and Tolerability Of Duloxetinementioning

confidence: 99%

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Duloxetine for the management of fibromyalgia syndrome

Scholz

Hammonds

Boomershine

2009

JPR

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Section: Safety and Tolerability Of Duloxetinementioning

confidence: 96%

Section: Dovepressmentioning

confidence: 99%

Section: Safety and Tolerability Of Duloxetinementioning

confidence: 99%

Section: Safety and Tolerability Of Duloxetinementioning

confidence: 99%

See 2 more Smart Citations

Duloxetine for the management of fibromyalgia syndrome

Scholz

Hammonds

Boomershine

2009

JPR

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“…Duloxetine, an antidepressant agent with an SNRI mechanism, is currently indicated for the treatment of major depressive disorder (MDD) in adults (9,10). In addition, it has been implicated to be a beneficial treatment for physical pain associated with depression and generalized anxiety disorder in adults (11)(12)(13)(14).…”

Section: Introductionmentioning

confidence: 99%

Preliminary Investigation on Duloxetine Efficacy in the Treatment of Children With Attention-Deficit Hyperactivity Disorder

2015

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Background: Stimulants are first-line agents for the treatment of attention-deficit/hyperactivity disorder (ADHD). Despite the impressive track record of stimulants in the treatment of ADHD, they fail in 25% of patients due to lack of efficacy or the emergence of unwanted side effects. Objectives: In this study, we investigated the efficacy and safety of duloxetine, a serotonin and norepinephrine reuptake inhibitor, in the treatment of children with attention-deficit hyperactivity disorder (ADHD). Patients and Methods:In an open label clinical trial, 13 children aged 6 -11 years diagnosed with ADHD were prescribed 30 mg/day duloxetine once daily by oral administration for six weeks. Conners Parent Rating Scale-Revised-Short form (CPRS-R-S) and the ADHD Rating Scale were used to assess the efficacy of the treatment. Results: Ten children with a mean age of 8.40 ± 1.67 years terminated the trial. A significant reduction in CPRS-R and its subscales was evident from week four of the study. In terms of side effects, duloxetine was generally safe and well tolerated. Conclusions: This preliminary assessment suggests that duloxetine may be a medication of interest in the treatment of children with ADHD. Further controlled studies with larger samples are required to evaluate the efficacy of duloxetine in treatment of children with ADHD.

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Trajectories of Depression Severity in Clinical Trials of Duloxetine

Gueorguieva¹

2011

Arch Gen Psychiatry

109

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Context The high percentage of failed clinical trials in depression may be due to high placebo response rates and the failure of standard statistical approaches to capture heterogeneity in treatment response. Objective To assess whether growth mixture modeling can provide insights into antidepressant and placebo responses in clinical trials of patients with major depression. Design We reanalyzed clinical trials of duloxetine to identify distinct trajectories of Hamilton Scale for Depression (HAM-D) scores during treatment. We analyzed the trajectories in the entire sample and then separately in all active arms and in all placebo arms. Effects of duloxetine hydrochloride, selective serotonin reuptake inhibitor (SSRI), and covariates on the probability of following a particular trajectory were assessed. Outcomes in different trajectories were compared using mixed-effects models. Setting Seven randomized double-blind clinical trials of duloxetine vs placebo and comparator SSRI. Patients A total of 2515 patients with major depression. Interventions Duloxetine and comparator SSRI. Main Outcome Measure Total score on the HAM-D. Results In the entire sample and in the antidepressant-treated subsample, we identified trajectories of responders (76.3% of the sample) and nonresponders (23.7% of the sample). However, placebo-treated patients were characterized by a single response trajectory. Duloxetine and SSRI did not differ in efficacy, and compared with placebo they significantly decreased the odds of following the nonresponder trajectory. Antidepressant responders had significantly better HAM-D scores over time than placebo-treated patients, but antidepressant nonresponders had significantly worse HAM-D scores over time than the placebo-treated patients. Conclusions Most patients treated with serotonergic antidepressants showed a clinical trajectory over time that is superior to that of placebo-treated patients. However, some patients receiving these medications did more poorly than patients receiving placebo. These data highlight the importance of ongoing monitoring of medication risks and benefits during serotonergic antidepressant treatment. They should further stimulate the search for biomarkers or other predictors of responder status in guiding antidepressant treatment. Trial Registration clinicaltrials.gov Identifier: NCT00073411

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Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo‐controlled clinical trials

Abstract: These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD.

Cited by 108 publications

References 43 publications

Duloxetine for the management of fibromyalgia syndrome

Duloxetine for the management of fibromyalgia syndrome

Preliminary Investigation on Duloxetine Efficacy in the Treatment of Children With Attention-Deficit Hyperactivity Disorder

Trajectories of Depression Severity in Clinical Trials of Duloxetine

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