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Citalopram for major depressive disorder in adults: a systematic review and meta-analysis of published placebo-controlled trials.

ABSTRACT: Objective To assess the effectiveness of citalopram for major depressive disorder (MDD) in adults, in a systematic review of all published, randomised, double-blind studies comparing it with a placebo. Data sources Cochrane Central Register of Controlled Trials, Medline, PsychINFO and Embase. Study selection Randomised, double-blind, placebo-controlled studies of citalopram in adults with MDD were included. Studies with medically ill or treatment resistant subjects were excluded, as were studies of relapse prevention. Remission of MDD was defined as a primary outcome, and response or change from baseline scores were defined as secondary. Data extraction Remission, response and symptom improvement scores on the Hamilton Depression Scale, Montgomery-Asberg Depression Rating Scale and Clinical Global Impressions-Severity scales were extracted. A random-effects meta-analysis was carried out on the response rates and symptom improvement scores. Included studies were examined for the presence of bias and small study effects. Results Eight studies (n=2025) met the inclusion criteria. Two studies provided data on remission, but only one of these showed a significant difference between citalopram and placebo (RR=1.59, 95% CI 1.10 to 2.31). Meta-analysis of response rates in five studies (n=1010) revealed significant superiority of citalopram (RR=1.42, 95% CI 1.17 to 1.73). Meta-analysis of change from baseline scores in five studies (n=1541) gave a standardised mean difference (Hedges' g) of -0.27 (95% CI -0.38 to to -0.16), showing a reduction in MDD symptoms to be significant for citalopram relative to placebo. There was no evidence of any significant small study effects. The overall quality of reporting was poor, with insufficient information on the methodology or outcomes. Seven studies received industry sponsorship. Conclusions Data concerning remission rates for citalopram, relative to placebo, are inconclusive. Response rates and symptom reduction scores in citalopram-treated patients with MDD are significantly better relative to placebo treatment, according to a meta-analysis of published reports. Evaluation of unpublished data is necessary to assess more definitively the effectiveness of citalopram for MDD.

SUBMITTER: Apler A

PROVIDER: S-EPMC3191585 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Citalopram for major depressive disorder in adults: a systematic review and meta-analysis of published placebo-controlled trials.

Apler Alex A

BMJ open 20110101 2

Objective To assess the effectiveness of citalopram for major depressive disorder (MDD) in adults, in a systematic review of all published, randomised, double-blind studies comparing it with a placebo. Data sources Cochrane Central Register of Controlled Trials, Medline, PsychINFO and Embase. Study selection Randomised, double-blind, placebo-controlled studies of citalopram in adults with MDD were included. Studies with medically ill or treatment resistant subjects were excluded, as were studi ...[more]

PMID: 22021869

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Project description:Vortioxetine was approved by the U.S. Food and Drug Administration (FDA) in September 2013 for treating major depressive disorder (MDD). Thus far, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with MDD. We performed a meta-analysis to increase the statistical power of these studies and enhance our current understanding of the role of vortioxetine in the treatment of MDD.We performed an extensive search of databases and the clinical trial registry. The mean change in total scores on the 24-item Hamilton Rating Scale for Depression (HAM-D) and the Montgomery- Åsberg Depression Rating Scale (MADRS) from the baseline were the primary outcome measures. The secondary efficacy measures were the response and remission rates, as defined by a 50% or greater reduction in HAM-D/MADRS total scores and as a score of 10 or less in the MADRS and 7 or less in the HAM-D total scores at the end of treatment.We included 7 published and 5 unpublished short-term (6-12 wk) RCTs in our meta-analysis. Vortioxetine was significantly more effective than placebo, with an effect size (standardized mean difference [SMD]) of -0.217 (95% confidence interval [CI] -0.313 to -0.122) and with odds ratios (ORs) for response and remission of 1.652 (95% CI 1.321 to 2.067) and 1.399 (95% CI 1.104 to 1.773), respectively. Those treated with vortioxetine did not differ significantly from those treated with selective norepinephrine reuptake inhibitors/agomelatine with regard to the SMD of the primary outcome measure (0.081, -0.062 to 0.223) or for response (OR 0.815, 95% CI 0.585 to 1.135) and remission (OR 0.843, 95% CI 0.575 to 1.238) rates. Discontinuation owing to lack of efficacy (OR 0.541, 95% CI 0.308 to 0.950) was significantly less common among those treated with vortioxetine than among those who received placebo, whereas discontinuation owing to adverse events (AEs; OR 1.530, 95% CI 1.144 to 2.047) was significantly more common among those treated with vortioxetine than among those receiving placebo. There was no significant difference in discontinuation rates between vortioxetine and comparators owing to inefficacy (OR 0.983, 95% CI 0.585 to 1.650), whereas discontinuation owing to AEs was significantly less common in the vortioxetine than in the comparator group (OR 0.728, 95% CI 0.554 to 0.957).Studies examining the role of vortioxetine in the treatment of MDD are limited.Although our results suggest that vortioxetine may be an effective treatment option for MDD, they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of heterogeneous RCTs.

Project description:BackgroundUnderstanding patterns of relapse in patients who respond to antidepressant treatment can inform strategies for prevention of relapse. We aimed to identify distinct trajectories of depression severity, assess whether similar or different trajectory classes exist for patients who continued or discontinued active treatment, and test whether clinical predictors of trajectory class membership exist using pooled data from clinical trials.MethodsWe analysed individual patient data from four double-blind discontinuation clinical trials of duloxetine or fluoxetine versus placebo in major depression from before 2012 (n=1462). We modelled trajectories of relapse up to 26 weeks during double-blind treatment. Trajectories of depression severity, as measured by the Hamilton Depression Rating Scale score, were identified in the entire sample, and separately in groups in which antidepressants had been continued or discontinued, using growth mixture models. Predictors of trajectory class membership were assessed with weighted logistic regression.FindingsWe identified similar relapse trajectories and two trajectories of stable depression scores in the normal range on active medication and on placebo. Active treatment significantly lowered the odds of membership in the relapse trajectory (odds ratio 0·47, 95% CI 0·37-0·61), whereas female sex (1·56, 1·23-2·06), shorter length of time with clinical response by 1 week (1·10, 1·06-1·15), and higher Clinical Global Impression score at baseline (1·28, 1·01-1·62) increased the odds. Overall, the protective effect of antidepressant medication relative to placebo on the risk of being classified as a relapser was about 13% (33% vs 46%).InterpretationThe existence of similar relapse trajectories on active medication and on placebo suggests that there is no specific relapse signature associated with antidepressant discontinuation. Furthermore, continued treatment offers only modest protection against relapse. These data highlight the need to incorporate treatment strategies that prevent relapse as part of the treatment of depression.FundingNational Institutes of Health, the US Department of Veterans Affairs Alcohol Research Center, and National Center for Post-Traumatic Stress Disorder.

Project description:BackgroundThe burden of depressive disorder is large and new treatment approaches are required. Repurposing widely available drugs such as statins may be a time- and cost-effective solution. Statins have anti-inflammatory and anti-oxidant properties which have been shown to be relevant to the pathophysiology of depression. This study assesses the efficacy, acceptability, tolerability, and safety of statins in major depressive disorder.MethodsOur study is an update and extension of a previous meta-analysis published in 2016 by Salagre et al. We performed a systematic review (PubMed/MEDLINE, Cochrane CENTRAL, ISI Web of Science, CINAHL, and ClinicalTrials.gov until the 1st September 2020) and meta-analysis of randomized controlled trials using any statin against placebo or any other statin in the treatment of major depressive disorder. Our primary efficacy outcome measure was the mean value on any standardized scale for depressive symptoms at 8 weeks of treatment. We also calculated outcomes for efficacy, response, and remission at 2, 4, and 12 weeks, as well as acceptability (dropouts for any cause), tolerability (dropouts due to any adverse event), and safety (any adverse event) outcomes at the studies' endpoints. Furthermore, we conducted an exploratory network meta-analysis for the primary efficacy outcome to identify potential differences between statins.ResultsWe retrieved five randomized controlled trials meeting our inclusion criteria: four used a statin in addition to an antidepressant and compared it to placebo plus antidepressant, and one compared two statins alone. and one comparing one statin with another. Statins compared to placebo in addition to antidepressants were efficacious at 8 weeks (N = 255, SMD = -0.48, 95% CI = -0.74 to -0. 22) and 12 weeks (N = 134, SMD = -0.47, 95% CI = -0.89 to -0.05, moderate certainty) with no difference for acceptability, tolerability, and safety (low certainty). An exploratory network meta-analysis suggested that the most lipophilic statins, especially simvastatin, could be more efficacious than less lipophilic or hydrophilic molecules.ConclusionsThis systematic review suggests the efficacy, acceptability, tolerability, and safety of statins in addition to antidepressants in patients with major depressive disorder. Further clinical trials in different settings are required to test this result.Trial rgistrationPROSPERO registration: CRD42020170938.

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Citalopram for major depressive disorder in adults: a systematic review and meta-analysis of published placebo-controlled trials.

Publications

Citalopram for major depressive disorder in adults: a systematic review and meta-analysis of published placebo-controlled trials.

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