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.
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ABSTRACT: Despite all the knowledge on depression, it is still unclear whether current literature covers all the psychosocial difficulties (PSDs) important for depressed patients. The aim of the present study was to identify the gaps in the recent literature concerning PSDs and their related variables. Psychosocial difficulties were defined according to the World Health Organization International Classification of Functioning, Disability and Health (ICF). A comparative approach between a systematic literature review, a focus group, and individual interviews with depressed patients was used. Literature reported the main psychosocial difficulties almost fully, but not in the same degree of importance as patients' reports. Furthermore, the covered areas were very general and related to symptomatology. Regarding the related variables, literature focused on clinical variables and treatments above all but did not report that many psychosocial difficulties influence other PSDs. This study identified many existing research gaps in recent literature mainly in the area of related variables of PSDs. Future steps in this direction are needed. Moreover, we suggest that clinicians select interventions covering not only symptoms, but also PSDs and their modifiable related variables. Furthermore, identification of interventions for particular psychosocial difficulties and personalisation of therapies according to individuals' PSDs are necessary.BioMed Research International 06/2014; 2014:319634. DOI:10.1155/2014/319634 · 2.71 Impact FactorThis article is viewable in ResearchGate's enriched formatRG Format enables you to read in context with side-by-side figures, citations, and feedback from experts in your field.
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ABSTRACT: This systematic review evaluated all published double-blind, randomized controlled antidepressant trials (RCTs) of acute phase treatment of older depressed patients. Meta-analyses were conducted in 51 double-blind RCTs of antidepressants in older patients. The results were also compared with 29 double-blind RCTs that did not produce extractable data to enter the meta-analysis. All classes of antidepressant (TCA's, SSRIs and other antidepressants) were more effective than placebo in achieving response. In achieving remission however, only pooling all 3 classes of antidepressants together showed a statistically significant difference from placebo. No differences were found in remission or response rates between classes of antidepressants. TCAs were also equally effective compared with SSRIs in achieving response in more severely depressed patients. The numbers needed to treat (NNT) were 14.4 (95% CI 8.3-50) for one additional remission to antidepressants compared with placebo and 6.7 (95% CI 4.8-10) for response. The results of the double-blind RCTs that did not produce extractable data to enter the meta-analysis were in concordance with the RCTs that were included in the meta-analysis. Only 4 RCTs were found that have not been published. Few studies have focused on severely depressed older people. Antidepressant treatment in older depressed patients is efficacious. We could not demonstrate differences in effectiveness between different classes of antidepressants; this was also the case in more severely depressed patients.Journal of Affective Disorders 04/2012; 141(2-3):103-15. DOI:10.1016/j.jad.2012.02.036 · 3.76 Impact Factor
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ABSTRACT: BACKGROUND: Depression is common in the elderly and in the last few years this led to a significant increase in antidepressant prescription rates. However, little is known about antidepressant efficacy profile in relation with socio-demographic and clinical features in this population. The aim of the present study was to define the most suitable socio-demographic and clinical profile for the use of antidepressant treatments in late-life depression. METHODS: MEDLINE, EMBASE and PsycINFO were searched for randomized controlled trials (RCTs) focused on efficacy of antidepressants of all classes in major depressed elderly subjects (>60 years old). Reviews and meta-analyses focusing on this topic have been considered as well. Thirty-four RCTs were included and socio-demographic and clinical features were investigated via meta-regression analysis as moderators of efficacy measures (standardized mean difference based on Hamilton Depressive Rating Scale and Montgomery-Asberg Depression Rating Scale). RESULTS: A lower rate of response to antidepressants of all classes was found in patients of male gender, of older age, and with a longer mean duration of the current episode. On the contrary, a higher rate of response was found in patients with a higher baseline severity and at their first episode of illness. Subsamples treated with selective serotonin reuptake inhibitors alone yielded similar results. LIMITATIONS: RCTs only have been included. CONCLUSIONS: A number of socio-demographic and clinical features have been found to moderate antidepressant efficacy in elderly population. Those variables could help clinicians for a more individualized treatment.Journal of Affective Disorders 12/2012; 147(1-3). DOI:10.1016/j.jad.2012.11.053 · 3.76 Impact Factor