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Journal of Clinical Psychopharmacology Dec 2006Uncertainty regarding relationships of antidepressant treatment and suicidality encouraged systematic review of data on suicidal behaviors and ideation from Phase II and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Uncertainty regarding relationships of antidepressant treatment and suicidality encouraged systematic review of data on suicidal behaviors and ideation from Phase II and III clinical trials of duloxetine for major depressive disorder (MDD).
METHODS
We evaluated all completed duloxetine trials in MDD with data lock by February 2, 2004. We compared incidence of suicide-related events with duloxetine versus placebo in controlled trials, using Mantel-Haenszel incidence difference (MHID) and exposure time-adjusted rate difference (MHRD) methods, and analyzed changes in Hamilton Depression Scale (HAMD) Item-3 (suicidality) scores.
RESULTS
There were no significant differences in the incidence of suicide-related events with duloxetine versus placebo in 12 placebo-controlled trials (duloxetine, 1812; placebo, 1184 [corrected] patients). The MHID for suicide-related behaviors was -0.03% (95% confidence interval [CI], -0.48 to 0.42) and MHRD -0.002 (95% CI, -0.02 to 0.02). Changes in HAMD Item-3 suicidality scores showed more improvement with duloxetine (MHID, 9.56%; 95% CI, 4.50 to 14.6; P < 0.001) and less worsening of suicidal ideation with duloxetine (MHID, -4.25%; 95% CI, -6.55 to -1.95; P < 0.001). Other Item-3 findings showed no consistent pattern; a slightly higher proportion of duloxetine-treated patients with a change from 0 (absent) to 3 was balanced against a higher proportion of placebo-treated patients changing from 0 to 2.
CONCLUSIONS
We found no evidence of an increased risk of suicidal behaviors or ideation during treatment with duloxetine compared with placebo in MDD patients. HAMD Item-3 suicidality scores had more improvement and less worsening of suicidal ideation with duloxetine than placebo.
Topics: Adult; Antidepressive Agents; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Depressive Disorder, Major; Double-Blind Method; Duloxetine Hydrochloride; Female; Humans; Incidence; Male; Psychiatric Status Rating Scales; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Suicide; Thinking; Thiophenes; Time Factors
PubMed: 17110815
DOI: 10.1097/01.jcp.0000246216.26400.db -
Schmerz (Berlin, Germany) Jun 2017The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017. (Review)
Review
BACKGROUND
The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled for April 2017.
METHODS
The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n =8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest. A literature search for systematic reviews of randomized controlled drug trials from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was achieved by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of available therapies were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines.
RESULTS AND CONCLUSION
Amitriptyline and duloxetine are recommended in the case of comorbid depressive disorders or generalized anxiety disorder and pregabalin in the case of generalized anxiety disorder. Off-label use of duloxetine and pregabalin can be considered if there are no comorbid mental disorders or no generalized anxiety disorder. Strong opioids are not recommended.
Topics: Amitriptyline; Anxiety Disorders; Comorbidity; Depressive Disorder; Duloxetine Hydrochloride; Evidence-Based Medicine; Fibromyalgia; Germany; Humans; Practice Guidelines as Topic; Pregabalin; Randomized Controlled Trials as Topic; Societies, Medical
PubMed: 28493231
DOI: 10.1007/s00482-017-0207-0 -
Annals of Clinical Psychiatry :... Nov 2019Anxiety in late-life is a frequently encountered condition. The aim of this review is to systematically examine the efficacy and tolerability of antidepressants for...
BACKGROUND
Anxiety in late-life is a frequently encountered condition. The aim of this review is to systematically examine the efficacy and tolerability of antidepressants for treating anxiety disorders among older adults.
METHODS
Electronic searches of The Cochrane Central Register of Controlled Trials and the standard bibliographic databases PubMed, MEDLINE, EMBASE, and PsycINFO were performed in August 2018 and updated in October 2018 for randomized controlled trials (RCTs) evaluating antidepressants for late-life anxiety. The quality of each study was appraised using criteria developed by the Centre for Evidence-Based Medicine.
RESULTS
Data from 12 papers describing 10 RCTs of antidepressants for late-life anxiety are included in this review. There were 2 studies each of sertraline, escitalopram, and duloxetine, and 1 study each of citalopram, paroxetine, venlafaxine, and imipramine. Across all trials, antidepressants were associated with a significant reduction in anxiety symptoms at the end of the study period. Limitations of the trials include a preponderance of generalized anxiety disorder and relatively less data on other anxiety disorders, and limited data on long-term use of antidepressants for anxiety.
CONCLUSIONS
Antidepressants are beneficial for treating anxiety disorders in late life and are generally well tolerated.
Topics: Aged; Antidepressive Agents; Anxiety Disorders; Citalopram; Duloxetine Hydrochloride; Humans; Late Onset Disorders; Paroxetine; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors; Sertraline
PubMed: 31369663
DOI: No ID Found -
Archives of Women's Mental Health Dec 2019The first aim of this article is to analyze the risk/benefit ratio of using psychotropic drugs approved in some countries for treating fibromyalgia syndrome (FMS) during...
The first aim of this article is to analyze the risk/benefit ratio of using psychotropic drugs approved in some countries for treating fibromyalgia syndrome (FMS) during pregnancy. Assessing the effectiveness of non-pharmacological interventions is the second scope of this article, in order to help clinicians to manage FMS in pregnancy in those countries were no drugs are approved for treating the disease. Following the PRISMA guidelines for systematic reviews, a literature search was conducted on PubMed and Google Scholar. Separate literature searches were performed for the three psychotropic drugs approved in the USA for treating FMS, psychotherapy, and transcranial magnetic stimulation (TMS). Perinatal duloxetine exposure is associated with increased risk of gestational and perinatal complications. With regards pregabalin, available information suggests that the drug is not devoid of structural teratogenicity potential. No data are available for milnacipran. Duloxetine and pregabalin should be only given to pregnant women diagnosed with severe forms of FMS after carefully weighing the benefits and risks for the mother-fetus dyad. On the other hand, we have to consider that the proportion of women who discontinue psychotropic drugs during pregnancy is as high as 85.4%. This figure raises further questions about adequate alternative treatment of FMS during the perinatal period. Moreover, neither duloxetine nor milnacipran or pregabalin have been approved by the EMEA for the treatment of FMS. Unfortunately, psychological treatment of FMS in perinatal women are not yet tested and data on TMS are conflicting.
Topics: Anti-Anxiety Agents; Duloxetine Hydrochloride; Europe; Female; Fibromyalgia; Humans; Milnacipran; Pregabalin; Pregnancy; Pregnancy Complications; Risk Assessment; Serotonin and Noradrenaline Reuptake Inhibitors; United States
PubMed: 30607517
DOI: 10.1007/s00737-018-0933-z -
Supportive Care in Cancer : Official... Feb 2015Chemotherapy-induced peripheral neuropathy (CIPN) is common among cancer patients who undergo chemotherapy with platinum analogues, taxanes, vinca alkaloids, epothilone,... (Review)
Review
PURPOSE
Chemotherapy-induced peripheral neuropathy (CIPN) is common among cancer patients who undergo chemotherapy with platinum analogues, taxanes, vinca alkaloids, epothilone, bortezomib, and thalidomide. The purpose of this study was to investigate the evidence of using drugs affecting the central nervous system (CNS) to alleviate CIPN in cancer patients.
METHODS
A systematic literature search was conducted using the CINAHL, EMBASE, and Medline databases to identify randomized controlled clinical trials (RCTs) reported in English up to 2013. We identified ten trials of CNS-acting drugs used to treat CIPN in cancer patients and reviewed efficacy and safety of CNS-acting drugs for CIPN using a standard data collection form. The risk of bias in each RCT was also assessed.
RESULTS
Antidepressants were used in six studies and anticonvulsants in four studies. We found positive results for amitriptyline (topical), venlafaxine, and oxcarbazepine in one study each, but the results were not sufficient to draw definite conclusions. One trial with duloxetine showed a moderate effect (effect size, 0.513, P = .003) on CIPN pain relief. However, none of the results has yet been duplicated in an RCT with a large sample size.
CONCLUSIONS
Insufficient RCTs exist to confirm the efficacy of CNS agents to reduce CIPN. This study highlighted the need for and the importance of conducting well-designed RCTs to generate evidence on CIPN symptom management. Additional RCTs are warranted to accelerate the potential use of CNS drugs for CIPN in cancer patients.
Topics: Amitriptyline; Anticonvulsants; Antidepressive Agents; Antineoplastic Agents; Boronic Acids; Bortezomib; Carbamazepine; Central Nervous System; Cyclohexanols; Duloxetine Hydrochloride; Epothilones; Humans; Neoplasms; Neuralgia; Oxcarbazepine; Peripheral Nervous System Diseases; Pyrazines; Taxoids; Thalidomide; Thiophenes; Venlafaxine Hydrochloride; Vinca Alkaloids
PubMed: 25256375
DOI: 10.1007/s00520-014-2408-8 -
Therapeutic Drug Monitoring Apr 2024Compared with antipsychotics, the relationship between antidepressant blood (plasma or serum) concentrations and target engagement is less well-established.
BACKGROUND
Compared with antipsychotics, the relationship between antidepressant blood (plasma or serum) concentrations and target engagement is less well-established.
METHODS
We have discussed the literature on the relationship between plasma concentrations of antidepressant drugs and their target occupancy. Antidepressants reviewed in this work are citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, duloxetine, milnacipran, tricyclic antidepressants (amitriptyline, nortriptyline, and clomipramine), bupropion, tranylcypromine, moclobemide, and vortioxetine. Four electronic databases were systematically searched.
RESULTS
We included 32 articles published 1996-2022. A strong relationship between serotonin transporter (SERT) occupancy and drug concentration is well established for selective serotonin reuptake inhibitors. Lower limits of recommended therapeutic reference ranges largely corroborate with the findings from positron emission tomography studies (80% SERT occupancy). Only a few novel studies have investigated alternative targets, that is, norepinephrine transporters (NETs), dopamine transporters (DATs), or monoamine oxidase A (MAO-A). For certain classes of drugs, positron emission tomography study data are inconclusive. Low DAT occupancy after bupropion treatment speculates its discussed mechanism of action. For MAO inhibitors, a correlation between drug concentration and MAO-A occupancy could not be established.
CONCLUSIONS
Neuroimaging studies are critical in TDM-guided therapy for certain antidepressants, whereas for bupropion and MAO inhibitors, the available evidence offers no further insight. Evidence for selective serotonin reuptake inhibitors is strong and justifies a titration toward suggested ranges. For SNRIs, duloxetine, and venlafaxine, NETs are sufficiently occupied, well above the SERT efficacy threshold. For these drugs, a titration toward higher concentrations (within the recommended range) should be considered in case of no response at lower concentrations.
Topics: Humans; Selective Serotonin Reuptake Inhibitors; Venlafaxine Hydrochloride; Bupropion; Duloxetine Hydrochloride; Monoamine Oxidase Inhibitors; Antidepressive Agents; Positron-Emission Tomography; Monoamine Oxidase
PubMed: 38287888
DOI: 10.1097/FTD.0000000000001142 -
European Journal of Oncology Nursing :... Jun 2022The aim in this review was to explore recent advances in chemotherapy-induced peripheral neuropathy (CIPN) management interventions and to identify the implications for...
PURPOSE
The aim in this review was to explore recent advances in chemotherapy-induced peripheral neuropathy (CIPN) management interventions and to identify the implications for practice and future research.
METHODS
A comprehensive search through seven electronic databases (AMED, CINAHL, Cochrane Library, EMBASE, PEDro, PubMed, and Web of Science) was conducted for studies published between January 1, 2013 and August 3, 2019. An updated search for subsequently published studies was made through PubMed on February 15, 2022. Randomized controlled trials (RCTs) involving either pharmacological or non-pharmacological interventions were considered eligible. The Cochrane Risk of Bias tool version 2.0 (RoB 2.0) was used to appraise the methodological risk of bias. Data extracted from the included RCTs were synthesized in a narrative approach.
RESULTS
Forty-two RCTs involving a total of 3393 participants were included. Overall, a high risk of bias was found in most of the included RCTs. The results further confirmed the analgesic effect of duloxetine on pain-related to CIPN. Exercise-based interventions, acupuncture, and several non-invasive neuromodulation techniques showed promise for managing CIPN.
CONCLUSIONS
The effects of most pharmacological and non-pharmacological interventions on CIPN are inconclusive due to methodological issues. Duloxetine remains the only pharmacological intervention recommended for managing pain related to CIPN. Although definitive recommendations cannot be made based on current research evidence, non-pharmacological interventions, especially non-invasive neuromodulation techniques, warrant future research.
Topics: Antineoplastic Agents; Duloxetine Hydrochloride; Humans; Pain; Pain Management; Peripheral Nervous System Diseases
PubMed: 35421796
DOI: 10.1016/j.ejon.2022.102134 -
Psychotherapy and Psychosomatics 2008Duloxetine inhibits both serotonin and norepinephrine reuptake and is marketed as a treatment for both the core emotional symptoms and painful physical complaints that... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Duloxetine inhibits both serotonin and norepinephrine reuptake and is marketed as a treatment for both the core emotional symptoms and painful physical complaints that often accompany depression. Some studies have found that duloxetine is efficacious in treating painful symptoms associated with depression but these findings have been inconsistent. Several narrative review articles have reached positive conclusions about the efficacy of duloxetine as an analgesic in depression but there has been no quantitative systematic review regarding the impact of duloxetine on pain among this population. A meta-analysis of data pertaining to duloxetine's purported analgesic effects on depressed patients was thus undertaken.
METHODS
Studies were selected through searching Medline and Cochrane Trial databases as well as examining Lilly's public clinical trial database. A random effects model was used.
RESULTS
Across five trials, the results indicate a very small (d = 0.115) and statistically nonsignificant (p = 0.057) analgesic effect for duloxetine. Additionally, some of the relevant data on duloxetine's effects have not been reported fully, making it likely that the obtained results reflect an overestimate of its true impact on painful physical symptoms in depression.
DISCUSSION
The current analysis is based on a small number of studies; further trials may yield significant results favoring duloxetine. Based upon the currently available evidence, the marketing of duloxetine as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.
Topics: Adult; Analgesics; Antidepressive Agents; Depressive Disorder; Double-Blind Method; Duloxetine Hydrochloride; Humans; Pain; Pain Measurement; Paroxetine; Psychophysiologic Disorders; Randomized Controlled Trials as Topic; Somatoform Disorders; Thiophenes; Treatment Outcome
PubMed: 18087203
DOI: 10.1159/000110055 -
Psychosomatics 2008Approximately two-thirds of patients with depression experience physical pain symptoms. Coexisting pain complicates the treatment of depression and is associated with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Approximately two-thirds of patients with depression experience physical pain symptoms. Coexisting pain complicates the treatment of depression and is associated with worse depression outcomes.
OBJECTIVE
The authors reviewed the effect of newer antidepressants on pain in patients with depression.
METHOD
The authors searched systematically for trials of second-generation antidepressants that enrolled depression patients and reported pain outcomes, pooling changes on the pain visual-analog scale (VAS), using random-effects models.
RESULTS
Eight trials were eligible. Pooled analysis of head-to-head trials showed no difference in VAS between duloxetine and paroxetine. Both drugs were superior to placebo.
CONCLUSION
The authors found insufficient evidence to support the choice of one second-generation antidepressant over another in patients with pain accompanying depression.
Topics: Antidepressive Agents, Second-Generation; Depression; Duloxetine Hydrochloride; Health Status; Humans; Pain; Pain Measurement; Paroxetine; Thiophenes
PubMed: 18448772
DOI: 10.1176/appi.psy.49.3.191 -
Revista Brasileira de Ginecologia E... Sep 2022To evaluate the effect of neuromodulatory drugs on the intensity of chronic pelvic pain (CPP) in women.
OBJECTIVE
To evaluate the effect of neuromodulatory drugs on the intensity of chronic pelvic pain (CPP) in women.
DATA SOURCES
Searches were carried out in the PubMed, Cochrane Central, Embase, Lilacs, OpenGrey, and Clinical Trials databases.
SELECTION OF STUDIES
The searches were carried out by two of the authors, not delimiting publication date or original language. The following descriptors were used: OR , associated with MESH/ENTREE/DeCS: , , , , , , , , , , , , , , , , and , with the Boolean operator . Case reports and systematic reviews were excluded.
DATA COLLECTION
The following data were extracted: author, year of publication, setting, type of study, sample size, intervention details, follow-up time, and results.
DATA SYNTHESIS
A total of 218 articles were found, with 79 being excluded because they were repeated, leaving 139 articles for analysis: 90 were excluded in the analysis of the titles, 37 after reading the abstract, and 4 after reading the articles in full, and 1 could not be found, therefore, leaving 7 articles that were included in the review.
CONCLUSION
Most of the studies analyzed have shown pain improvement with the help of neuromodulators for chronic pain. However, no improvement was found in the study with the highest statistical power. There is still not enough evidence that neuromodulatory drugs reduce the intensity of pain in women with CPP.
Topics: Amitriptyline; Anticonvulsants; Antidepressive Agents; Antidepressive Agents, Tricyclic; Chronic Pain; Citalopram; Duloxetine Hydrochloride; Female; Gabapentin; Humans; Imipramine; Norepinephrine; Nortriptyline; Pelvic Pain; Pregabalin; Serotonin; Sertraline; Venlafaxine Hydrochloride
PubMed: 36044916
DOI: 10.1055/s-0042-1755459