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Oxybutynin reduces sweating in depressed patients treated with sertraline: a double-blind, placebo-controlled, clinical study  [cached]
Ghaleiha A,Jahangard L,Sherafat Z,Ahmadpanah M
Neuropsychiatric Disease and Treatment , 2012,
Abstract: Ali Ghaleiha,1 Leila Jahangard,1 Zahra Sherafat,1 Mohammad Ahmadpanah,1 Serge Brand,2 Edith Holsboer-Trachsler,2 Hafez Bajoghli,3 Mohammad Haghighi11Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran; 2Psychiatric Hospital of the University of Basel, Center for Affective, Stress and Sleep Disorders, University of Basel, Basel, Switzerland; 3Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, IranBackground: Selective serotonin reuptake inhibitors are primarily used in the pharmacological treatment of patients experiencing a major depressive disorder. However, one of the common unwanted effects is excessive sweating or hyperhidrosis. Oxybutynin is an anticholinergic medication which reduces sweating. The aim of this double-blind study was to examine the effect of administration of oxybutynin on subjective sweating in patients treated with sertraline.Methods: A total of 140 patients experiencing a major depressive disorder (mean age 37.69 ± 10.44 years, 86 females [61.4%]) treated with sertraline (mean dose 83 mg/day) were consecutively enrolled in the study, and all reported excessive sweating as a side effect. Thereafter, the patients were randomly assigned to either an oxybutynin 5 mg/day group or to a placebo group. At the beginning and end of the 2-week trial, the patients completed questionnaires related to sweating and medication-related side effects.Results: Over time, subjective sweating reduced significantly in the treatment group as compared with the control group. Oxybutynin-induced side effects were uncommon. Relative to male patients, female patients reported less subjective sweating.Conclusion: Administration of oxybutynin successfully reduced excessive sweating in patients experiencing a major depressive disorder and treated with sertraline. However, possible gender effects should be taken into account.Keywords: oxybutynin, sweating, sertraline, major depressive disorders
Oxybutynin reduces sweating in depressed patients treated with sertraline: a double-blind, placebo-controlled, clinical study
Ghaleiha A, Jahangard L, Sherafat Z, Ahmadpanah M, Brand S, Holsboer-Trachsler E, Bajoghli H, Haghighi M
Neuropsychiatric Disease and Treatment , 2012, DOI: http://dx.doi.org/10.2147/NDT.S36329
Abstract: utynin reduces sweating in depressed patients treated with sertraline: a double-blind, placebo-controlled, clinical study Original Research (1763) Total Article Views Authors: Ghaleiha A, Jahangard L, Sherafat Z, Ahmadpanah M, Brand S, Holsboer-Trachsler E, Bajoghli H, Haghighi M Published Date September 2012 Volume 2012:8 Pages 407 - 412 DOI: http://dx.doi.org/10.2147/NDT.S36329 Received: 24 July 2012 Accepted: 10 August 2012 Published: 14 September 2012 Ali Ghaleiha,1 Leila Jahangard,1 Zahra Sherafat,1 Mohammad Ahmadpanah,1 Serge Brand,2 Edith Holsboer-Trachsler,2 Hafez Bajoghli,3 Mohammad Haghighi1 1Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran; 2Psychiatric Hospital of the University of Basel, Center for Affective, Stress and Sleep Disorders, University of Basel, Basel, Switzerland; 3Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran Background: Selective serotonin reuptake inhibitors are primarily used in the pharmacological treatment of patients experiencing a major depressive disorder. However, one of the common unwanted effects is excessive sweating or hyperhidrosis. Oxybutynin is an anticholinergic medication which reduces sweating. The aim of this double-blind study was to examine the effect of administration of oxybutynin on subjective sweating in patients treated with sertraline. Methods: A total of 140 patients experiencing a major depressive disorder (mean age 37.69 ± 10.44 years, 86 females [61.4%]) treated with sertraline (mean dose 83 mg/day) were consecutively enrolled in the study, and all reported excessive sweating as a side effect. Thereafter, the patients were randomly assigned to either an oxybutynin 5 mg/day group or to a placebo group. At the beginning and end of the 2-week trial, the patients completed questionnaires related to sweating and medication-related side effects. Results: Over time, subjective sweating reduced significantly in the treatment group as compared with the control group. Oxybutynin-induced side effects were uncommon. Relative to male patients, female patients reported less subjective sweating. Conclusion: Administration of oxybutynin successfully reduced excessive sweating in patients experiencing a major depressive disorder and treated with sertraline. However, possible gender effects should be taken into account.
Treatment of functional dyspepsia with sertraline: A double-blind randomized placebo-controlled pilot study  [cached]
Victoria PY Tan,Tin K Cheung,Wai M Wong,Roberta Pang
World Journal of Gastroenterology , 2012, DOI: 10.3748/wjg.v18.i42.6127
Abstract: AIM: To evaluate sertraline, a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia. METHODS: Consecutive tertiary hospital patients with a clinical diagnosis of functional dyspepsia (FD) according to the Rome II criteria with a Hong Kong dyspepsia index (HKDI) of greater than 16 were recruited. Patients commenced enrolment prior to the inception of the Rome III criteria for functional dyspepsia. All patients were ethnic Chinese, had a normal upper endoscopy and were Helicobacter pylori negative prior to enrolment. Study patients were randomized to receive sertraline 50 mg or placebo daily for 8 wk. HKDI symptom scores, quality of life, hospital anxiety and depression (HAD) scale and global symptom relief were evaluated before, during and after treatment. Adverse effects were monitored during and after treatment. RESULTS: A total of 193 patients were randomized in the intention to treat (ITT), and 150 patients were included in the per protocol (PP) analysis. In both the ITT and PP, there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8. In the ITT analysis, 98 and 95 patients were randomized to the sertraline and placebo groups respectively. A total of 43 patients withdrew from the study (22.3%) by week 8, with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4 (95.8%). In contrast, in the placebo arm, 11 of 19 patients dropped out by week 4 (57.9%). Utilizing the last response carried forward to account for the drop-outs, there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI, HKDI 26.08 ± 6.19 vs 26.70 ± 5.89, P = 0.433; and at week 8, HKDI 22.41 ± 6.36 vs 23.25 ± 7.30, P = 0.352 respectively. In the PP analysis, 74 and 76 patients were randomized to the sertraline and placebo groups respectively. At baseline, there were no statistically significant differences between the sertraline and placebo groups, HKDI 25.83 ± 6.313 vs 27.19 ± 5.929 respectively, P = 0.233; however by week 8, patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo, HKDI 20.53 ± 6.917 vs 23.34 ± 7.199, P = 0.02, respectively). There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the ITT or PP analysis at week 8. CONCLUSION: This pilot study, the first to examine sertraline, a selective serotonin reuptake inhibitor, for the management
Efficacy and tolerability of mirtazapine versus sertraline: an open, randomized study in acute treatment in patients with major depressive disorder  [PDF]
S Dahal,SI Ojha,M Chapagain,P Tulachan
Journal of Psychiatrists' Association of Nepal , 2014, DOI: 10.3126/jpan.v3i1.11349
Abstract: Introduction: Mirtazapine is the first noradrenergic and specific serotonergic antidepressant (NaSSA). It has demonstrated efficacy that is significantly superior to older and newer anti-depressant in the initial weeks of treatment in western studies. The specific pharmacologic profile of mirtazapine also means that it lacks many of the serotonergic side effects, in particular, sexual dysfunction. The effectiveness of sertraline is well established in major depression. Aim: The aim of the study was to compare the anti-depressant efficacy and tolerability of mirtazapine and sertraline in treatment of patients with a diagnosis of major depressive episode attending Psychiatry department of Tribhuvan University Teaching Hospital. Methodology: A total of 60 patients meeting the inclusion criteria were selected. These patients were diagnosed as depression as per the ICD-10 DCR criteria and were randomized to 6 week treatment with either mirtazapine (N=30, 15-45 mg/day) or sertraline (N=30, 50-150mg/day). Efficacy was evaluated by the HAMD scale, Clinical Global Impression scales (CGI) and UKU side effect rating scale was used for any adverse event noted during study period. Assessments were done on baseline and week 2, 4 and 6. Result: The primary efficacy variable (mean absolute change from baseline in HAMD score) showed that mirtazapine was significantly (p < 0.05) more effective than sertraline at assessment during 2 and 4 weeks of the study after which there was no statistically significant differences in efficacy (p >0.05) between two drugs. There was statistically significant reduction in CGI- mean severity of illness rating scale score at 2 week ( p< 0.05) in mirtazapine treated patients compared to sertraline after which reduction of score was similar in both group. Both treatments were well tolerated. Tension (57.6%) , palpitation / tachycardia (26.9%), sexual dysfunction (22.9%) were more frequent in sertraline treated patients compared to nausea / vomiting (26.9%) , sleepiness / sedation (23.0%), increased duration of sleep (23.0%) in mirtazapine treated patients. Conclusion: Mirtazapine was well tolerated and was equally effective as sertraline in reducing depressive symptoms. However, mirtazapine was significantly more effective than sertraline after 2 and 4 week of treatment. The findings need to be confirmed with other large scale studies. DOI: http://dx.doi.org/10.3126/jpan.v3i1.11349 J Psychiatrists’ Association of Nepal Vol .3, No.1, 2014: 29-34
Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder
Helen Christensen, Adam J Guastella, Andrew J Mackinnon, Kathleen M Griffiths, Claire Eagleson, Philip J Batterham, Kanupriya Kalia, Justin Kenardy, Kylie Bennett, Ian B Hickie
Trials , 2010, DOI: 10.1186/1745-6215-11-48
Abstract: 120 community-dwelling participants, aged 18-30 years with a clinical diagnosis of GAD will be recruited from the Australian Electoral Roll. They will be randomly allocated to one of three conditions: (i) an online treatment program for GAD, E-couch (ii) pharmacological treatment with a selective serotonin re-uptake inhibitor (SSRI), sertraline (a fixed-flexible dose of 25-100 mg/day) or (iii) an attention control placebo, HealthWatch. The treatment program will be completed over a 10 week period with a 12 month follow-up.As of February 2010, there were no registered trials evaluating the effectiveness of an e-health application for GAD for young adults. Similarly to date, this will be the first trial to compare an e-health intervention with a pharmacological treatment.Current Controlled Trials ISRCTN76298775Generalised anxiety disorder is a high prevalence psychiatric disorder that is associated with low rates of treatment. The predominant symptom of GAD is excessive uncontrollable worry in a variety of domains that lasts for a period of at least six months. Associated symptoms include muscle tension, becoming fatigued easily, restlessness, irritability, and sleep disturbance [1]. Lifetime and 12 month prevalence rates have been estimated at between 4.3-5.9% and 1.2-1.9% respectively [2,3]. However, a relatively small percentage of those with GAD seek treatment. Findings from the US National Comorbidity Survey indicated that only 37% of respondents had sought treatment for the disorder [4].The condition generally follows a chronic course, with symptoms often presenting early in the lifespan and affecting individuals throughout adulthood. There is an estimated delay of treatment following the initial onset of symptoms for the affected individual of between 9 and 23 years [5]. Consequently, the community cost associated with GAD is high [6]. Effective treatment in young adulthood has the potential to reduce ongoing disability and costs [7,8]. Young adults (18-30 year
Clinical review of treatment options for major depressive disorder in patients with coronary heart disease
Fahad Alosaimi,Brian Baker
Saudi Medical Journal , 2012,
Abstract: It is established that the prevalence of major depressive disorder (MDD) in coronary heart disease (CHD) populations is high and is associated with increased mortality. In this systematic review, we examined the evidence for the effective treatment of MDD in CHD patients by reviewing randomized control trials (RCTs)between 1980 and 2011 and then assessing whether these treatments were clinically meaningful. A total of 8 RCTs were retrieved. Sertraline, citalopram, and mirtazapine were safe from a cardiac perspective, but only sertraline and citalopram were clearly more effective than placebo in CHD patients with moderate-to-severe type, recurrent MDD, or MDD episode onset before the CHD event. Augmenting sertraline with omega-3 fatty acids did not result in superior depression outcomes. Cognitive-behavioral therapy was equivocally superior to usual care. Interpersonal psychotherapy was only superior to clinical management in patients with high baseline functional status. Exercise is a potential treatment for those with mild depression.
A 6 Week Randomized Double-Blind Placebo-Controlled Trial of Ziprasidone for the Acute Depressive Mixed State  [PDF]
Ashwin Patkar, William Gilmer, Chi-un Pae, Paul A. V?hringer, Michael Ziffra, Edward Pirok, Molly Mulligan, Megan M. Filkowski, Elizabeth A. Whitham, Niki S. Holtzman, Sairah B. Thommi, Tanya Logvinenko, Antony Loebel, Prakash Masand, S. Nassir Ghaemi
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0034757
Abstract: Objective To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD). Methods 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d) or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE), while also meeting 2 or 3 (but not more nor less) DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery- ?sberg Depression Rating Scale (MADRS) scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. Results The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038). Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036). Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. Conclusions There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. Trial Registration Clinicaltrials.gov NCT00490542
SENSITIVE AND SELECTIVE SPECTROPHOTOMETRIC DETERMINATION OF SERTRALINE IN PHARMACEUTICALS USING PICRIC ACID  [cached]
Pinderjit Singh
International Journal of Pharmaceutical Research and Development , 2011,
Abstract: An accurate and precise visible spectrophotometric method is presented for the determination of sertraline in pharmaceutical formulation. Sertraline forms a yellow colored product in the presence of picric acid in chloroform and the absorbance of yellow colored species formed was measured at 415 nm against reagent blank and Beer’s law was obeyed in the concentration range of 3 to 95 μg/mL. The amount of sertraline present in the sample was computed from calibration curve. Result of percentage recovery and placebo interference shows that the method was not affected by the presence of common excipients. The percentages assay of sertraline in tablet was more than 99%. The method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of sertraline in bulk and solid dosage form.
Quetiapine monotherapy in acute phase for major depressive disorder: a meta-analysis of randomized, placebo-controlled trials
Narong Maneeton, Benchalak Maneeton, Manit Srisurapanont, Stephen D Martin
BMC Psychiatry , 2012, DOI: 10.1186/1471-244x-12-160
Abstract: This meta-analysis aimed to determine the efficacy, acceptability and tolerability of quetiapine treatment for major depressive disorder (MDD). Only the randomized controlled trials (RCTs) comparison between quetiapine and placebo were included. The authors searched such clinical trials carried out between 1991 and February 2012.MEDLINE, EMBASE, CINHL, PsycINFO and Cochrane Controlled Trials Register were searched in February 2012. Study populations comprised adults with MDD or major depression.Eligible studies were randomized, placebo-controlled trials of quetiapine monotherapy carried out in adults with MDD and presenting endpoint outcomes relevant to: i) depression severity, ii) response rate, iii) overall discontinuation rate, or iv) discontinuation rate due to adverse events. No language restriction was applied.All abstracts identified by the electronic searches were examined. The full reports of relevant studies were assessed, and the data of interest were extracted. Based on the Cochrane methods of bias assessment, risks of bias were determined. The studies with two risks or less were included. The efficacy outcomes were the mean change scores of depression rating scales, the overall response rate, and the overall remission rates. The overall discontinuation rate was considered as a measure of acceptability. The discontinuation rate due to adverse events was a measure of tolerability. Relative risks (RRs) and weighted mean differences (WMDs) with 95% confidence intervals (CIs) were computed by using a random effect model.A total of 1,497 participants in three RCTs were included. All trials examined the quetiapine extended-release (XR). The pooled mean change scores of the Montgomery-Asberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating Scale (HAM-D) of the quetiapine-treated group were higher than those of the placebo-treated group with the WMDs (95%CI) of -3.37 (-3.95, -2.79) and -2.46 (-3.47, -1.45), respectively. All studies defined the
Efficacy and Safety of Vortioxetine and Duloxetine 60 mg Compared Placebo for the Treatment of Major Depressive Disorder: A Systematic Review and Meta-Analysis  [PDF]
Masoud Behzadifar, Abouzar Keshavarzi, Abed Tofighian, Mohammad Rastian, Mohammad Zobidi, Ali Akbari Sari
Journal of Behavioral and Brain Science (JBBS) , 2015, DOI: 10.4236/jbbs.2015.510041
Abstract: Background: Major depressive disorder is a serious public health problem affecting the lives of millions in the worldwide and leading causes of disability and disease. This study aimed to evaluate the efficacy and safety of Vortioxetine and Duloxetine 60 mg compared to placebo for the treatment of major depressive disorder. Method: We searched the Cochrane library, Pub Med, CRD, Scopus, and Central Register of Controlled Trials to January 2015. We also searched ClinicalTrials.gov, International depressive disorder Conference and the Anxiety Disorders and Depression Conference. We identified that five randomized clinical trials were ultimately included in a Meta analysis. Data analysis was conducted by Standardized Mean Differences (SMD) for Montgomery-Åsberg Depression Rating Scale (MADRS), and Odds Ratio (OR) for adverse events. The SMD and OR reported by 95% CI. Results: Results showed statistical significance in the MADRS for Vortioxetine (SMD = ﹣3.29; 95% CI ﹣4.47 to ﹣2.10; I2 = 99.3%) and for Duloxetine 60 mg (SMD = ﹣6.35; 95% CI ﹣8.84, ﹣3.87; I2 = 99.3%). Results showed that the Vortioxetine 2.5, 5, 10, 15, 20 mg and overall compared to placebo showed a significance for Nausea and no significance for diarrhea, dry mouth, dizziness, fatigue and headache. Also results of Duloxetine 60 mg showed a significant effect for dry mouth, dizziness, fatigue and nausea. Conclusion: It is necessary to do more studies so as to better assess and much more powerful than the evidence for the use of this drug in the treatment of depression.
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