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Antidepressant side effects may have implications with regard to patient safety as well as the overall tolerability of treatment. Side effects relevant to patient safety can contribute to an increased risk of morbidity and mortality, but may or may not result in patient distress or discomfort. In contrast, side effects related to tolerability can contribute to patient discomfort but are not associated with an immediate increase in risk of morbidity or mortality. Common tolerability-related side effects of modern antidepressants include nausea, insomnia, somnolence, fatigue, sexual dysfunction, and weight gain. Because these side effects can result in patient discomfort and distress, they can lead to poor compliance or noncompliance with treatment that, in turn, may result in an increased risk of depressive relapse or recurrence. Modern antidepressants have varying tolerability profiles, and clinicians should be vigilant about balancing treatment efficacy with side effects when choosing antidepressants. This article compares the rates of common tolerability-related side effects among the newer (post-tricyclic era) antidepressants with the selective serotonin reuptake inhibitors, the most popular contemporary first-line treatment for depression.
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PMID:Tolerability of modern antidepressants. 1849 38

Fluvoxamine is a selective-serotonin reuptake inhibitor (SSRI) that has proved effective in large double-blind, randomized, controlled trials involving patients with social anxiety disorder (SAD), obsessive-compulsive disorder (OCD), and panic disorder. Improvements have also been demonstrated in patients with post-traumatic stress disorder, as well as those with a range of obsessive-compulsive spectrum disorders including binge eating disorder, bulimia nervosa, pathological gambling, and body dysmorphic disorder. Several well controlled studies have confirmed the efficacy of fluvoxamine in children and adolescents with OCD, SAD, and other anxiety disorders, and it was the first SSRI to be registered for the treatment of OCD in children. Fluvoxamine is well tolerated. In common with other SSRIs, the most frequently reported adverse event is nausea. Fluvoxamine does not cause sedation or cognitive impairment and is associated with a low risk of sexual dysfunction, suicidality, and withdrawal reactions. It is safe in overdose and has no significant effect on body weight or cardiovascular parameters.
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PMID:Fluvoxamine in the treatment of anxiety disorders. 1856 10

The primary aim of this study was to investigate significance of the naltrexone in the management of drug addiction. A total of 108 opiate dependent drug abusers were included in this study. The study period was May 2004 to March 2008. They were selected consecutively on the basis of defined criteria. Of 108 drug abusers, 81.48% were literate and rest was illiterate. In current profession, majority of them (81.48%) had no work; rests were businessmen (13.89%) or service holders (4.63%). Nearly 72.22% drug abusers were young adult had age 20-30 years and 71.30% were married. About 94.00% of them were using heroin. In lifetime, sixty percent of them had been using heroin or phensedyl for 3-5 years, 25.93% for 6-10 years and 13.89% for 11-16 years. Hundred percent of the studied drug abusers had habit of smoking cigarettes. Most of them were heterosexual having sex with multiple partners. Nocturnal insomnia, difficulty falling asleep or hypersomnia, antisocial and/or irritable behaviors were found among them. About 75.00% of them had altered food habit and 45.37% had sexual dysfunction. Eighty-four percent wives of the participant drug abusers were found to be literate and 84.42% had only household works in their profession. Illiteracy was found to be higher in mother (26.85%) than that of father (24.07%). Majority of the father were found to be businessmen and mothers had household works only. Their family income was Tk.10,000-20,000 monthly. In addition, disharmony among family members, illicit drug users and mental illness were found in 81.48%, 23.15% and 21.30% families respectively. About 95.00% of the participant drug abusers were completed treatment schedule with naltrexone successfully and rest were dropout. Only 45.37% of them were developed adverse effects; of which, insomnia, nausea vomiting, headache, abdominal cramps and nervousness were found to be notable. Finally, 75.93% participant drug abusers were relapsed and rest (25.49%) was remained abstinent from illicit drug use. Multiple factors were found to be liable to use illicit drugs once more. Of them, unpleasant emotional state, sexual dysfunction, friend's incitement, family disharmony and interpersonal conflict were found to be crucial important. All of the participants were acknowledged essentiality of the Naltrexone in the treatment of drug addiction. They expressed their satisfaction during treatment including abstinent period. Most of them had not physical or mental craving for illicit drugs as before treatment and did not mention sleep disturbance or other mental troubles. They had normal food habit, increased appetite and taste preference in abstinent period. However, naltrexone could play important role in demand reduction but has no effect to enhance self-efficacy. In combination with self-efficacy enhancement therapies, it would be effective in the treatment of opioids dependence.
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PMID:Naltrexone in drug addiction: significance in the prevention of relapse. 1937 33

Anxiety disorders are persistent impairing diseases, with often chronic course and suffering from symptoms throughout a life-span. The medication with the most evidence of efficacy is the benzodiazepines having a low incidence of side effects but may cause physical dependence, withdrawal and sedation. The use of these drugs should be limited to the acute treatments during the first several weeks in combination with an SSRI or and SNRI for the treatment of the acute phase. After three to four weeks, when antidepressants become effective, benzodiazepine dose should be tapered over a one week period. Among the antidepressants, the SSRI and the SNRI are considered a first-line therapy because of their favourable side effect spectrum compared to tricyclic antidepressants. However, the association with side effects such as nausea, sweating, sexual dysfunction and gastrointestinal problems and insomnia may be intolerable for a number of patients. Combining antidepressants and benzodiazepine therapy or medication treatment and psychotherapy may lead to an increase in improvement in patients not responding to one treatment approach alone. The most effective treatment for managing the recurrent symptoms of this chronic disorder are still unknown and other studies and approaches are in need as remission rates are still only about 40%.
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PMID:[Treatment strategies in anxiety disorders--an update]. 1949 38

Premature ejaculation (PE) is a common problem in men worldwide. It has a significant impact on affected men and their partners in terms of self-esteem, dissatisfaction with their sexual relationships, personal distress, and interpersonal difficulty. Psychological therapies may achieve short-term improvements, but there are limited data on the long-term success of these methods. Oral therapy with long-acting selective serotonin reuptake inhibitors (SSRIs) improves intravaginal ejaculatory latency time (IELT), but these agents are designed to be administered daily and may be associated with unwanted sexual side effects and withdrawal symptoms upon abrupt discontinuation. Dapoxetine is a short-acting SSRI that can be taken as needed (prn) by men with PE. It has been studied in five separate multicenter, randomized, double-blind, placebo-controlled trials involving more than 6000 men with PE. In four studies that evaluated IELT as an endpoint (N = 4843), dapoxetine 30 and 60 mg prn achieved statistically significant increases in IELT versus placebo. Dapoxetine also showed statistically significant improvements in perceived control over ejaculation, PE-related personal distress, and other patient-reported outcomes in all five trials. Dapoxetine treatment is generally well-tolerated, with low incidences of discontinuation syndrome, sexual dysfunction, and treatment-emergent mood symptoms. The most common adverse events with dapoxetine included nausea, diarrhea, headache, dizziness, and somnolence.
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PMID:Emerging treatments for premature ejaculation: focus on dapoxetine. 1955 98

The efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) once-daily monotherapy in generalized anxiety disorder (GAD) was assessed. This multicentre, double-blind, randomized, placebo- and active-controlled, phase III trial consisted of a 1- to 4-wk enrolment/wash-out period and a 10-wk (8-wk active treatment, 2-wk post-treatment drug-discontinuation) study period; 873 patients were randomized to 50 mg or 150 mg quetiapine XR, 20 mg paroxetine, or placebo. Primary endpoint was change from randomization at week 8 in Hamilton Rating Scale for Anxiety (HAMA) total score. At week 8, all active agents produced significant improvements in HAMA total and psychic subscale scores vs. placebo; HAMA somatic subscale scores were significantly reduced only by 150 mg quetiapine XR. Significant separation from placebo (-2.90) in HAMA total score was observed at day 4 for 50 mg quetiapine XR (-4.43, p<0.001) and 150 mg quetiapine XR (-3.86, p<0.05), but not for paroxetine (-2.69). Remission (HAMA total score 7) rates at week 8 were significantly higher for 150 mg quetiapine XR (42.6%, p<0.01) and paroxetine (38.8%, p<0.05) vs. placebo (27.2%). The most common adverse events (AEs) were dry mouth, somnolence, fatigue, dizziness, and headache, for quetiapine XR, and nausea, headache, dizziness for paroxetine. A lower proportion of patients reported sexual dysfunction with quetiapine XR [0.9% (50 mg), 1.8% (150 mg)] than with placebo (2.3%) or paroxetine (7.4%). The incidence of AEs potentially related to extrapyramidal symptoms was: quetiapine XR: 50 mg, 6.8%, 150 mg, 5.0%; placebo, 1.8%; and paroxetine, 8.4%. Once-daily quetiapine XR is an effective and generally well-tolerated treatment for patients with GAD, with symptom improvement seen as early as day 4.
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PMID:Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. 1969 7

Venlafaxine is a serotonin-noradrenaline reuptake inhibitor (SNRI) that has no affinity for muscarinic, adrenergic or histaminergic receptors. In short-term trials, the adverse effects that occurred more often with venlafaxine than with placebo included nausea, somnolence, dizziness, dry mouth, and sweating. Rapid titration of the dose of venlafaxine to higher levels appeared, not unexpectedly, to be associated with an increased incidence of side effects. Side effects that appeared to be dose related included insomnia, nausea and sexual dysfunction. The incidence of nausea and dizziness was highest during the first 2 or 3 weeks of therapy and decreased rapidly thereafter. Somnolence also decreased over time. At high doses blood pressure increases were reported in a small percent of patients on venlafaxine and antidepressant drugs but were uncommon at the venlafaxine dose of 75-150 mg daily. Studies with venlafaxine in healthy volunteers indicate a low potential for drug-drug interactions. Overdoses have been reported in 14 of 3,082 patients administered venlafaxine in clinical trials, and no deaths were reported among these patients. Overdoses of venlafaxine induced mainly drowsiness and lethargy.
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PMID:Neurobiologic basis of antidepressant safety profiles. 1969 84

Major depressive disorder (MDD) affects <or= 15% of the general population and imparts a significant economic and psychosocial burden. Despite the availability of a wide range of drugs for treating MDD, the majority of patients fail to achieve complete and sustained remission of symptoms. Vilazodone is a novel dual-acting serotonergic antidepressant currently in clinical development for the treatment of MDD. Vilazodone combines the effects of a selective serotonin reuptake inhibitor with 5-HT(1A) receptor partial agonist activity. In a recent Phase III clinical trial, vilazodone showed significant antidepressant efficacy compared to placebo with a statistically significant onset of effect at 1 week. Overall dropout rates were low. Diarrhea, nausea and headache were the most common adverse events reported. In addition, there was no significant difference between placebo and vilazodone in terms of sexual dysfunction as measured by the Arizona Sexual Experiences Scale. A unique feature of the vilazodone clinical program is the concurrent development of biomarkers that may predict treatment response and common side effects. Vilazodone offers a dual mechanism of action, good general tolerability with the potential for less impairment of sexual function than selective serotonin reuptake inhibitors and the possibility of personalized treatment for MDD.
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PMID:Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depression. 1976 90

Bupropion, a noradrenaline/dopamine reuptake inhibitor, and venlafaxine, a serotonin/noradrenaline reuptake inhibitor, are both established antidepressants with proven efficacy in randomized controlled clinical trials. The objective of this double-blind, randomized, placebo- and active-controlled, eight-week, flexible-dose study was to evaluate the efficacy and tolerability of the once-daily extended-release formulations of these two antidepressants compared with placebo. Patients with major depressive disorder were randomized to once-daily treatment with bupropion XR 150 mg (n = 204), the extended-release formulation of venlafaxine (venlafaxine XR) 75 mg (n = 198) or placebo (n = 189) during weeks 1 to 4, with the option to double the dose at week 5 if response was inadequate. In this study, bupropion XR did not demonstrate statistically significant evidence of greater improvement from baseline compared with placebo on week 8 Montgomery Asberg Depression Rating scale scores (primary endpoint) or on secondary endpoints including CGI, HAM-A and responder and remitter analyses. Descriptive statistics for venlafaxine XR indicated separation versus placebo on MADRS total scores at week 8 and other intermediate time points, and on other endpoints including CGI, HAM-A and responder and remitter analyses. Both active treatments elicited improvement on the Sheehan Disability Scale and its subscales and were generally well tolerated at the doses studied. Rates of nausea, dry mouth, dizziness, hyperhidrosis, insomnia, constipation, tremor, anorexia and male sexual dysfunction were elevated in the venlafaxine XR group, consistent with its mixed serotonergic/noradrenergic mechanism. Rates of dry mouth, insomnia and hyperhidrosis were elevated in the bupropion XR group, consistent with its catecholaminergic mechanism.
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PMID:Double-blind, placebo-controlled comparison of the antidepressant efficacy and tolerability of bupropion XR and venlafaxine XR. 1993 70

A wide variety of antidepressants are available today for treating major depressive disorder. However, like all medical therapies, antidepressants have several limitations that clinicians should consider when choosing treatments for their patients. This article reviews the efficacy, tolerability, and safety of the newer (ie, posttricyclic era) antidepressants. Specifically, overall efficacy and efficacy in relation to specific depressive symptoms and patient subpopulations, as well as in relation to various psychiatric and medical comorbidities, are addressed, along with tolerability profiles with respect to common side effects, including nausea, fatigue, insomnia, somnolence, sexual dysfunction, and weight gain. Finally, the safety profile of these agents is summarized.
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PMID:The efficacy, tolerability, and safety of contemporary antidepressants. 2037 Oct 30


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