Duloxetine in the treatment of major depressive disorder: A placebo- and paroxetine-controlled trial
Lilly Research Center, Erl Wood, Sunninghill Road, Windlesham, Surrey GU20 6PH, UK. European Psychiatry
(Impact Factor: 3.44).
10/2006; 21(6):367-78. DOI: 10.1016/j.eurpsy.2006.03.004
Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder (MDD).
In this randomized, double-blind trial, patients age > or =18 meeting DSM-IV criteria for MDD were randomized to placebo (N=99), duloxetine 80 mg/day (N=93), duloxetine 120 mg/day (N=103), or paroxetine 20 mg/day (N=97). The primary outcome measure was mean change from baseline in the 17-item Hamilton rating scale for depression (HAMD(17)) total score after 8 weeks of treatment; a number of secondary efficacy measures also were assessed. Safety and tolerability were assessed via collection and analysis of treatment-emergent adverse events (TEAEs), vital signs, and weight. The Arizona sexual experiences scale was used to assess sexual functioning. Patients who had a > or =30% reduction from baseline in the HAMD(17) total score at the end of the acute phase entered a 6-month continuation phase where they remained on the same treatment as they had taken during the acute phase; efficacy and safety/tolerability outcomes were assessed during continuation treatment.
More than 87% of patients completed the acute phase in each treatment group. Duloxetine-treated patients (both doses) showed significantly greater improvement (P<0.05) in the HAMD(17) total score at week 8 compared with placebo. Paroxetine was not significantly different from placebo (P=0.089) on mean change on the HAMD(17). Duloxetine 120 mg/day also showed significant improvement on most secondary efficacy measures (six of nine) compared with placebo while duloxetine 80 mg/day (three of nine) and paroxetine (three of nine) were significantly superior to placebo on fewer secondary measures. HAMD(17) mean change data from this study and an identical sister study were pooled as defined a priori for the purposes of performing a non-inferiority test versus paroxetine. Both duloxetine doses met statistical criteria for non-inferiority to paroxetine. TEAE reporting rates were low in all treatment groups and no deaths occurred in the acute or continuation phases.
The efficacy of duloxetine at doses of 80 and 120 mg/day in the treatment of MDD was demonstrated. Tolerability, as measured by TEAEs, and safety were similar to paroxetine 20 mg/day and consistent with previous published data on duloxetine in the treatment of MDD.
Available from: Mark Demitrack
- "Similar to the publications noted above for continuous outcomes, this latter report is informative since the author had full access to the entire registration dossier for this pharmaceutical agent and so was able to summarize information on both positive and negative clinical trial results. For two of the more recently approved antidepressants , duloxetine and selegiline (transdermal patch), the sponsors' peer-reviewed primary data publications were utilized as these appeared to represent nearly exhaustive summaries of their respective development programs (Detke, 2002a, 2002b; Goldstein, 2002, 2004; Perahia, 2006; Feiger, 2006; Bodkin, 2002). The majority of the reference comparison datasets that we have used consist of studies performed in patients preferentially recruited based on the prior likelihood of response to treatment, i.e., patients "
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ABSTRACT: Transcranial magnetic stimulation (TMS) is a novel treatment for patients with major depressive disorder. Although clearly safer and better tolerated than many other pharmacotherapeutic options or electroconvulsive therapy, questions have persisted about the magnitude of the efficacy of TMS in patients with pharmacoresistant depression, and the clinical significance of these outcomes. Previous studies have explored whether specific patient characteristics are associated with a greater likelihood of clinical benefit. In the largest such analysis conducted to date, the authors confirmed previous observations that the lower the number of prior failed antidepressant treatments, the better the clinical outcome of treatment with TMS. This relationship between prior treatment resistance and subsequent treatment outcome is consistent with previous evidence from antidepressant studies. The authors examined the clinical significance of the treatment effects seen with TMS in pharmacoresistant major depression in their recently completed studies by comparing these outcomes with the results reported in several large, comprehensive published reference datasets of antidepressant medications studied in both treatment-responsive and treatment-resistant patient populations. The efficacy of TMS demonstrated in randomized controlled trials was comparable to that of pharmaceutical antidepressants studied in similarly designed registration trials and to the adjunctive use of atypical antipsychotic medications in controlled trials of antidepressant non-responders. These data may be helpful in treatment-planning decisions when using TMS in clinical practice.
Psychopharmacology bulletin 02/2009; 42(2):5-38. · 0.50 Impact Factor
Available from: Louise Howard
- "With regard to the most recent antidepressants, escitalopram appears as well tolerated as other SSRIs (possibly better than paroxetine) and better tolerated than venlafaxine (Baldwin, et al., 2007). Studies with duloxetine have reported both equal and poorer tolerability compared with SSRIs (Hudson, et al., 2005; Perahia, et al., 2006; Khan, et al., 2007; Wade, et al., 2007; Lee, et al., 2007) but fewer sexual side effects than paroxetine (Delgado, et al., 2005). In pooled data from two studies against venlafaxine more patients on duloxetine discontinued overall, and due to side effects, (NNH about 20) (Perahia, et al., 2007) RCTs are probably not the best way to assess the impact of tolerability in practice. "
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ABSTRACT: A revision of the 2000 British Association for Psychopharmacology evidence-based guidelines for treating depressive disorders with antidepressants was undertaken to incorporate new evidence and to update the recommendations where appropriate. A consensus meeting involving experts in depressive disorders and their management was held in May 2006. Key areas in treating depression were reviewed, and the strength of evidence and clinical implications were considered. The guidelines were drawn up after extensive feedback from participants and interested parties. A literature review is provided, which identifies the quality of evidence to inform the recommendations, the strength of which are based on the level of evidence. These guidelines cover the nature and detection of depressive disorders, acute treatment with antidepressant drugs, choice of drug versus alternative treatment, practical issues in prescribing and management, next-step treatment, relapse prevention, treatment of relapse, and stopping treatment.
Journal of Psychopharmacology 07/2008; 22(4):343-96. DOI:10.1177/0269881107088441 · 3.59 Impact Factor
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ABSTRACT: A revision of the British Association for Psychopharmacology guidelines for treating depressive disorders with antidepressants was undertaken in order to specify the scope and target of the guidelines and to update the recommendations based explicitly on the available evidence. A consensus meeting, involving experts in depressive disorders and their treatment, reviewed key areas and considered the strength of evidence and clinical implications. The guidelines were drawn up after extensive feedback from participants and interested parties. A literature review is given which identifies the quality of evidence followed by recommendations, the strength of which are based on the level of evidence. The guidelines cover the nature and detection of depressive disorders, acute treatment with antidepressant drugs, choice of drug versus alternative treatment, practical issues in prescribing, management when initial treatment fails, continuation treatment, maintenance treatment to prevent recurrence and stopping treatment.
Journal of Psychopharmacology 04/2000; 14(1):3-20. DOI:10.1177/026988110001400101 · 3.59 Impact Factor
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