Low doses of controlled-release paroxetine in the treatment of late-life depression: A randomized, placebo-controlled trial
ABSTRACT To evaluate the efficacy and tolerability of low daily doses of controlled-release (CR) paroxetine in patients with late-life depression.
This was a 10-week, multicenter, placebo-controlled, double-blind, fixed-dose trial randomly assigning patients >or= 60 years old to daily doses of paroxetine CR 12.5 mg (N = 168), paroxetine CR 25 mg (N = 177), or placebo (N = 180). Patients had major depressive disorder (DSM-IV criteria) and 17-item Hamilton Rating Scale for Depression (HAM-D) total scores of >or= 18. The primary efficacy variable was the change from baseline to study endpoint in total HAM-D scores. The study was conducted from June 2003 to October 2004.
The drug/placebo difference in HAM-D change from baseline at study endpoint was -1.8 (95% CI = -3.41 to -0.19, p = .029) for paroxetine CR 12.5 mg, and -3.3 (95% CI = -4.84 to -1.68, p < .001) for paroxetine CR 25 mg. A significantly larger percentage of patients achieved remission (HAM-D total score <or= 7 at endpoint) with paroxetine CR 25 mg (41%), but not with 12.5 mg (31%), as compared with placebo (28%) (p = .008). Both doses of paroxetine CR also achieved statistical significance compared to placebo for the Clinical Global Impressions-Severity of Illness scale (p < .01) and the patient-rated measures of depression severity (p < .05) and quality of life (p <or= .001). Both active treatments were generally well tolerated, with adverse event withdrawal rates of 6%, 8%, and 7% for paroxetine CR 12.5 mg, paroxetine CR 25 mg, and placebo, respectively.
These data demonstrate that paroxetine CR 12.5 mg and 25 mg daily are efficacious and well tolerated in the treatment of major depressive disorder in patients >or= 60 years of age, although effect sizes are relatively smaller with the 12.5 mg/day dose.
- SourceAvailable from: Peter Krummenacher
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- "Differences between Hedges's g were calculated using a one-way ANOVA, whereas the effect sizes were weighted by the sample size divided by s 2 (i.e., n/var; Lipsey and Wilson, 2001). Four studies included two treatment groups and one placebo group (Katona et al., 2012; Rapaport et al., 2003, 2009; Schatzberg and Roose, 2006). To deal with the resulting dependency in these cases, we included both comparisons using the same mean for each placebo sub-group but used half the sample size for n when weighting (n/var) the means of the placebo group in each comparison. "
ABSTRACT: Baseline severity is a crucial moderator of trial outcomes in adult depression, with the advantage of antidepressants over placebo increasing as severity increases. However, this relationship has not been examined in late-life depression. PubMed, Embase, Web of Science, PsycINFO, and Cochrane were searched for studies published through September 2014. Randomized, acute phase, and double-blind studies comparing an antidepressant group with a placebo group in depressed elderly patients were included. Nineteen studies met all inclusion criteria. Within-group effect sizes revealed significant improvement in antidepressant groups (g=1.35, p<.000), as well as in placebo groups (g=.96, p<.000). Change in depressive symptoms assessed by Hamilton Depression Rating Scale (HDRS) was moderated by baseline severity in antidepressant groups (Z=2.67, p=.008) and placebo groups (Z=4.46, p<.000). However, this would be expected as a result of regression toward the mean, and mean differences between groups did not increase (r=.19, p=.469) as a function of baseline severity. Limited to published data and information was only analyzed at the level of treatment groups. Baseline severity was not associated with an antidepressant-placebo difference and placebo responses are large in the treatment of depressed elderly people. We propose a stepwise approach, i.e., to initially offer elderly depressed patients psychosocial interventions and only consider antidepressants if patients do not respond. Copyright © 2015 Elsevier B.V. All rights reserved.Journal of Affective Disorders 04/2015; 181:50-60. DOI:10.1016/j.jad.2015.03.062 · 3.71 Impact Factor
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ABSTRACT: Despite the great burden of depression on sufferers and society, there is a lack of reliable information regarding the full range of psychosocial difficulties associated with depression and their related variables. This systematic review aimed to demonstrate the utility of the International Classification of Functioning, Disability and Health (ICF) in describing the psychosocial difficulties that shape the lived experience of persons with depression. An electronic search that included publications from 2005 to 2010 in the MEDLINE and PsycHINFO databases was conducted to collect psychosocial outcomes. Quality of studies was also considered. 103 studies were included. 477 outcomes referring psychosocial difficulties were extracted and grouped into 32 ICF related categories. Emotional functions (19% of studies), followed by energy and drive (17% of studies), were the most frequent psychosocial outcomes. The onset, course, determinants, and related variables of the most important psychosocial difficulties, reported in at least 10% of studies, were described. Medication played a dual role as determinant of onset and change in some psychosocial areas, e.g. in pain, sleep, and energy and drive. The search was limited by year of publication and focused only on minor and major depression diagnoses: other depressive disorders were not included. Some underresearched, but relevant psychosocial areas could have not been analyzed. The present systematic review provides information on the psychosocial difficulties that depressive patients face in their daily lives. Future studies on depression should include outcome instruments that cover these relevant areas in order to comprehensively describe psychosocial functioning.Journal of Affective Disorders 12/2011; 141(1):22-33. DOI:10.1016/j.jad.2011.12.009 · 3.71 Impact Factor
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ABSTRACT: INTRODUCTION: A growth in the market for antidepressants, paired with an ever-increasing population affected from depressive disorder, requires a critical re-evaluation of most prescribed antidepressants, in order to provide up-to-date practical prescribing information for clinicians. Paroxetine represents a widely prescribed and reliable antidepressant for the expert clinician, but the latest data do not rank it amongst the most effective and tolerable newer antidepressants. AREAS COVERED: This paper reviews latest data on paroxetine and investigates its clinical efficacy and safety in different groups of patients. EXPERT OPINION: In previous subanalysis and metaregression analysis, paroxetine failed to show clear differences in terms of efficacy across clinical subgroups. Thus, nowadays the pharmacokinetic and pharmacodynamic properties of the molecule are fundamental to guiding its prescription, both for efficacy and tolerability issues, for example, it can have a high impact on sexual function and weight should also be considered at the beginning of treatment. Since prescription is still based mainly on its side-effect profile, newer and more accurate directions for an individualized prescription are needed.Expert Opinion on Pharmacotherapy 02/2012; 13(3):421-31. DOI:10.1517/14656566.2012.652085 · 3.09 Impact Factor