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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Seventy-seven patients with a primary diagnosis of social phobia (DSM-III-R) were randomized to treatment with the reversible and selective monoamine oxidase type A inhibitor brofaromine (n = 37) or placebo (n = 40) for 12 weeks in a double-blind trial. A fixed dose of 150 mg/day or a matching placebo was given after a 2-week dose titration phase. Patients with additional diagnoses of simple phobia, generalized anxiety disorder, dysthymia or major depressive disorder currently in remission were accepted. Patients with other Axis I mental disorders were excluded. In the brofaromine group, 78% of the patients scored much or very much improved on the Clinical Global Impression scale compared with 23% in the placebo group. The anxiety and avoidance scores on the Liebowitz Social Anxiety Scale (LSAS) were significantly reduced in favor of brofaromine. The clinical effects were not significantly correlated with the plasma concentration of brofaromine. After 12 weeks the brofaromine group scored significantly lower than the placebo group on a core depression part of the Montgomery-Asberg Depression Rating Scale. After 12 weeks of treatment the brofaromine group had significantly higher total scores on the LSAS than an age- and gender-matched group of healthy controls. The brofaromine group improved further during 9-month follow-up treatment period, whereas 60% of the placebo responders who continued long-term treatment relapsed. The most common side effects in the brofaromine group were sleep disturbances, dry mouth and nausea.
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PMID:Social phobia: the clinical efficacy and tolerability of the monoamine oxidase -A and serotonin uptake inhibitor brofaromine. A double-blind placebo-controlled study. 861 39

Current antidepressants achieve similar efficacy, with 60% to 80% of patients responding adequately. Clinical response is gradual, and differential response factors are difficult to discern. However, side effect profiles and toxicity vary substantially, so the choice of medication depends primarily on tolerability and safety. Dry mouth is prevalent with tricyclic antidepressants (TCAs), whereas nausea occurs more frequently with a serotonin selective reuptake inhibitor (SSRI). Long-term unwanted effects tend not to be a major problem, with a dropout rate of approximately 5% due to side effects. The relationship between suicidality and antidepressants remains under debate. Many TCAs are highly toxic in overdose whereas the SSRIs appear much safer. Nefazodone is a unique antidepressant with demonstrated efficacy. It is different from other antidepressants because of its two actions in the serotonin system, moderate serotonin selective reuptake blocking properties and direct 5-HT2 antagonism, which also can enhance 5-HT1 neurotransmission. The 5-HT2 antagonist properties may limit serotonin-mediated effects and, as a result, nefazodone may be more anxiolytic than other antidepressants. Nefazodone also moderately inhibits norepinephrine reuptake and blocks alpha 1-adrenergic receptors. The data base on the safety of nefazodone currently comprises approximately 3,500 patients from all research trials, which include controlled trials that allow comparisons of nefazodone treatment with several hundred patients taking TCAs or SSRIs and nearly 900 patients receiving placebo. The most frequent adverse experiences with nefazodone as compared with placebo treatment are nausea (21% vs. 14%), somnolence (19% vs. 13%), dry mouth (19% vs. 13%), dizziness (12% vs. 6%), constipation (11% vs. 7%), asthenia (11% vs. 6%), light-headedness (10% vs. 4%), and amblyopia (blurred vision; 6% vs. 3%). Approximately 12% of nefazodone-treated patients dropped out because of adverse experiences, as compared with 7.4% on placebo, 10.4% on SSRIs, but 21.8% on imipramine after short-term exposure in placebo-controlled trials. Long-term safety data include nearly 1,300 patients; nefazodone was well tolerated. Nefazodone was evaluated in normal subjects by the author and was found to produce less impairment than imipramine and was less likely to interact with alcohol. In summary, nefazodone has a favorable adverse-event profile as compared with the TCAs and a rather different one from the SSRIs. It appears to be safe and well tolerated after both acute and long-term use.
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PMID:Tolerability and safety: essentials in antidepressant pharmacotherapy. 862 62

The therapeutic dose range of nefazodone for treatment of major depression was examined in a series of placebo-controlled efficacy studies carried out during phase 2 and 3 premarketing clinical evaluation. Nefazodone is a new antidepressant drug with pharmacologic effects on both serotonin and norepinephrine neurotransmitters. The usual starting dose of nefazodone for depressed patients, unless they are being switched from a serotonin selective reuptake inhibitor (SSRI), is 100 mg. b.i.d. A lower starting dose is recommended for elderly patients or patients being treated with an SSRI. Following assessment of the patient's clinical response after the first week of therapy, the daily dose should be adjusted upward for most patients. In the efficacy studies, the majority of patients were being maintained on a dose of 300 to 500 mg daily at the end of the acute treatment period. The side effects of nefazodone most often related to dosage were sedation, nausea, and visual symptoms. Imipramine-treated patients, on the other hand, had a high incidence of dry mouth, constipation, and asthenia. In these studies, nefazodone was found to be effective and well tolerated by patients, the majority of whom were being maintained at a 300- to 500-mg/day dose, following an initial starting dose of 100 mg b.i.d.
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PMID:Therapeutic dose range of nefazodone in the treatment of major depression. 862 65

The efficacy and safety of fluvoxamine maleate, a selective serotonin reuptake inhibitor, was compared with placebo and imipramine in patients with major depressive disorder. Previous literature has cited a dose range of 100 to 300 mg/day of fluvoxamine maleate for the treatment of major depression; however, this study demonstrates that a dose range of 50 to 150 mg/day is as effective as imipramine (80-240 mg/day). After a 1- to 2-week, single-blind, placebo washout phase, 150 depressed outpatients were randomized to double-blind treatment with fluvoxamine maleate (50-150 mg/day), imipramine (80-240 mg/day), or placebo for 6 weeks. Fluvoxamine produced a significant therapeutic benefit over placebo (p < or = 0.05) as assessed by the total score on the Hamilton Rating Scale for Depression; imipramine (80-240 mg/day) produced similar results. The secondary outcome variables (i.e., Clinical Global Impression severity of illness item and 56-Item Hopkins Symptom Checklist depression factor) also showed significant differences between fluvoxamine maleate and placebo during three of the four final weeks of the study. Both fluvoxamine maleate and imipramine appeared to be safe and well tolerated by the majority of patients. As expected from the pharmacology of these agents, the imipramine groups reported more anticholinergic effects (dry mouth, dizziness, and urinary retention) and electrocardiographic effects, whereas the fluvoxamine group reported more nausea, somnolence, and abnormal ejaculation. The majority of these adverse events were mild to moderate and, with the exception of dry mouth (imipramine) and abnormal ejaculation (fluvoxamine), were transient. The data clearly demonstrate the antidepressant activity and tolerability of fluvoxamine maleate (50-150 mg/day) as compared with placebo; it is also as effective as the tricyclic antidepressant imipramine (80-240 mg/day) in patients with major depressive disorder.
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PMID:Fluvoxamine maleate in the treatment of depression: a single-center, double-blind, placebo-controlled comparison with imipramine in outpatients. 869 Aug 26

Since citalopram was first approved in 1989, it has been prescribed to an estimated > 600 000 patients. An integrated safety database has been prepared, including data from 3107 patients from 24 clinical trials. In placebo-controlled trials, nausea, dry mouth, somnolence, increased sweating, tremor, diarrhoea, and ejaculation failure, mostly of mild to moderate severity, occurred significantly (p < 0.05) more frequently with citalopram. The excess incidence of these events over placebo was always less than 10%. In pooled comparative studies, citalopram's tolerability profile was similar to that of other selective serotonin reuptake inhibitors (SSRIs) and superior to that of tricyclic antidepressants (TCAs). Spontaneous adverse event reports arising from clinical use have confirmed the safety profile defined during the trials programme. Specific monitoring of all serious adverse events from around 10 000 patients receiving citalopram in clinical trials (including small open studies) has indicated a low potential for convulsions and extrapyramidal effects. There is no evidence of withdrawal phenomena on abrupt discontinuation, no clinically relevant effects on cardiac or laboratory parameters, and little or no effect on psychomotor function. When taken in overdose alone, citalopram appears to have a relatively wide margin of safety. Citalopram has been well tolerated in both short- and long-term use, and the profile seen in trials has been confirmed in the clinic.
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PMID:The safety and tolerability of citalopram. 873 43

The chemistry, pharmacology, pharmacokinetics, and clinical efficacy of nefazodone hydrochloride, a new antidepressant, are described. Nefazodone enhances serotonin (5-hydroxytryptamine [5-HT]) synaptic transmission by acting as an antagonist at 5-HT2 receptors and by inhibiting the reuptake of 5-HT. These two mechanisms combined may enhance 5-HT1A-mediated transmission. In addition, nefazodone weakly inhibits the reuptake of norepinephrine. Nefazodone is a structural analogue of trazodone but is pharmacologically distinct. In placebo-controlled trials, nefazodone was as effective as imipramine for the treatment of major depression and produced clinical benefits in patients with depression-related anxiety and sleep disturbances. More than 2000 patients have received nefazodone in clinical trials. The most commonly reported adverse drug reactions (ADRs) are asthenia, somnolence, dry mouth, nausea, constipation, dizziness, lightheadedness, confusion, abnormal vision, and blurred vision. The incidence of sexual-dysfunction ADRs may be less than that reported for other antidepressants. Nefazodone does not inhibit rapid-eye movement sleep. Nefazodone, an inhibitor of the hepatic P-450 isoenzyme CYP3A4, may increase concentrations of drugs metabolized by this isoenzyme, such as terfenadine, astemizole, triazolam, alprazolam, and midazolam. Caution should be exercised in administering nefazodone hydrochloride with triazolobenzodiazepines, and coadministration with terfenadine or astemizole is contra-indicated. The dosage should start at 100 mg twice daily and then be increased, depending on occurrence of ADRs and the patient's clinical response, to 300-600 mg daily. In elderly or debilitated patients, the initial dosage should be half the usual dosage. Nefazodone hydrochloride is as effective as other available antidepressants and may cause fewer ADRs.
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PMID:Nefazodone: a new antidepressant. 889 78

Approximately 20 million patients suffer from major depressive disorder each year, indicating a need for antidepressant agents that are synonymous with effectiveness, tolerability and patient compliance. The authors examined the effects of fluvoxamine, a selective serotonin reuptake inhibitor, in the treatment of outpatients meeting DSM-III-R criteria for major depressive disorder. A randomized, double-blind, parallel group, placebo- and imipramine-controlled single center study was conducted in 150 outpatients. Patients were randomized to receive up to 150 mg/day of fluvoxamine as a single bedtime dose, 240 mg/day of imipramine on a twice-daily (BID) schedule, or placebo for six weeks. Efficacy measurements included HAM-D, MADRS, CGI, Raskin-Covi and SCL-56 scales. The HAM-D total score indicated that both active treatment groups showed significantly (p < or = 0.05) greater therapeutic benefit than did placebo. Severely depressed patients (HAM-D > or = 30) responded better to fluvoxamine in five of six measures. Side-effects from fluvoxamine were similar to those reported for other selective serotonin reuptake inhibitors (nausea, somnolence) and were well tolerated. Imipramine was associated with anticholinergic effects such as dry mouth and dizziness. The pharmacokinetic properties of fluvoxamine which allow the drug to be administered as a single daily dose should aid in the maintenance of patient compliance, while offering significant clinical benefit in the improvement of depressive symptoms.
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PMID:Fluvoxamine versus imipramine and placebo: a double-blind comparison in depressed patients. 880 49

The efficacy of the second generation antihistamine ebastine has been investigated in the treatment and prevention of seasonal allergic rhinitis (SAR). In a double-blind randomised study, patients treated with a single daily dose of ebastine 10mg (n = 116) for 2 weeks showed a significant improvement in symptoms of SAR compared with those treated with placebo (n = 85). Sneezing, rhinorrhoea, tears and conjunctival irritation were all significantly improved, but not blocked nose. The overall efficacy of treatment was judged to be significantly superior in the ebastine group. There was no increase in bodyweight at the end of the study in either of the groups. There was no increase bodyweight at the end of the study in either of the groups. The percentage of patients reporting adverse events were headache, somnolence, nausea, dry mouth, stomach upset and increased appetite. The efficacy of ebastine 10 mg/day (n = 111) was similar to that of astemizole 10 mg/day (n = 106) over a 4-month period in preventing the symptoms of SAR in the open randomised study. The efficacy of both drugs in preventing the onset of sneezing, rhinorrhoea, blocked nose and tears was significant, when symptoms were compared with those during the previous year. At the end of the study, the astemizole-treated patients had a significant increase in bodyweight, which was not observed in the ebastine group. The percentage of patients reporting adverse events was significantly greater in the astemizole group (34.9% versus 20.7%; p = 0.02). Thus, ebastine is a useful alternative treatment for seasonal allergic rhinitis. It has also shown efficacy comparable to that of astemizole in the prevention of onset of symptoms of this allergic condition, and appears to be better tolerated than this agent.
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PMID:Clinical efficacy of ebastine in the treatment and prevention of seasonal allergic rhinitis. 882 25

A 12-month open-label clinical trial was conducted to evaluate patient acceptance and safety of venlafaxine, a novel antidepressant, in ambulatory geriatric depressed patients. The sample consisted of 58 depressed patients aged 65 years and older who needed long-term antidepressant treatment. The setting was multiple study sites in California, Florida, New York, Utah, and Washington. All patients took venlafaxine; 52 qualified for the intent-to-treat analysis, and 24 completed 12 months of treatment. Repeated-measures analysis of variance within subjects showed significant improvements in Clinical Global Impressions severity and improvement, Modified Symptom Checklist, and Quality of Life Questionnaire scores. One patient developed a rash that was judged to be a serious drug-related side effect. The most common side effects were headache (n = 25), nausea (n = 21), insomnia (n = 18), dry mouth (n = 18), and sweating (n = 18). The results demonstrate the safety and patient acceptance of venlafaxine in depressed geriatric outpatients for acute and maintenance treatment.
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PMID:Venlafaxine in depressed geriatric outpatients: an open-label clinical study. 885 49

During the last two decades, there has been a trend to use low-dose I-131 ablation therapy in patients with thyroid carcinoma without metastases. However, information regarding the incidence of acute adverse reactions in patients after low-dose radioiodine therapy has not been reported. In this study, the acute radiation effects after low-dose radioiodine ablation therapy in postsurgical differentiated thyroid cancer patients was evaluated. Fifty-six patients with differentiated thyroid cancer were prospectively evaluated. None of these patients had evidence of a distant metastasis. All patients received 40 mCi (1480 MBq) I-131 MIBG orally and were evaluated for symptoms and signs by a physician on the second and seventh days after therapy. Xerostomia and nausea were the most common complaints with the same incidence rate of 5.35%. Gastralgia occurred at a frequency of 3.57%. Pain in the thyroid bed, tenderness over a parotid gland, submandibular glands, change in taste, and vomiting all were found at a frequency of 1.78%. Maximum reactions generally occurred 24-48 hours after therapy. All the symptoms except for xerostomia resolved completely in most patients within a week. In comparison with high-dose ablation therapy published in the literature, the incidence of radiation reactions in low-dose radioiodine therapy was much lower. It was concluded that in patients without lymph node or distant metastases, low-dose I-131 MIBG therapy may be recommended to avoid the high incidence of local complications after high-dose treatment.
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PMID:Short-term hazards of low-dose radioiodine ablation therapy in postsurgical thyroid cancer patients. 889 26


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