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

Results are presented of the first double-blind, placebo-controlled trial of a novel antidepressant venlafaxine, which preclinically has demonstrated serotonin, norepinephrine, and dopamine reuptake inhibiting effects. Sixty outpatients meeting DSM-III-R criteria for major depression were randomized to receive 6 weeks of treatment with one of three fixed doses of venlafaxine--25 mg three times a day, 75 mg three times a day, or 125 mg three times a day--or placebo. Significant improvement was observed in depression scores at all doses, with the high dose resulting in earlier improvement, by week 2. For the combined venlafaxine treatment groups, 68% achieved a moderate or marked improvement on the Clinical Global Impression scale, compared with only 31% for the placebo group. Venlafaxine was well tolerated, and nervousness, sweating, and nausea were the only adverse effects observed more frequently with drug compared with placebo.
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PMID:Placebo-controlled trial of venlafaxine for the treatment of major depression. 191 21

Venlafaxine is a structurally novel compound with a biochemical and pharmacological profile suggesting antidepressant properties. We report the results of a Phase II, double-blind, placebo-controlled clinical trial assessing the efficacy and safety of venlafaxine in a sample of 93 depressed outpatients. Venlafaxine doses of 25 mg t.i.d., 75 mg t.i.d., and 125 mg t.i.d. were compared to placebo. Patients receiving venlafaxine showed a significantly greater improvement in their mood symptoms compared to those receiving placebo. Venlafaxine was well tolerated and the most common side effect was nausea. There was some evidence to suggest that venlafaxine may have antidepressant activity within the first 2 weeks of treatment.
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PMID:Venlafaxine in depressed outpatients. 192 60

Venlafaxine has been shown in clinical trials to be safe and well tolerated in patients with major depression. Data were pooled from 19 studies in which 2181 patients were given venlafaxine, 451 were given placebo and 591 were given a reference antidepressant (imipramine, trazodone, clomipramine, maprotiline, dothiepin or amineptine). Long-term safety was evaluated in 422 patients who were given venlafaxine for at least 1 year; as well, a total of 229 elderly patients have been treated with venlafaxine, including 66 who were given it for at least 1 year. The adverse events that occurred during short-term treatment in > or = 10% of patients were nausea, headache, insomnia, somnolence, dry mouth, dizziness, constipation, asthenia, sweating and nervousness. In comparator-controlled trials, the frequency of anticholinergic events with the reference agents was approximately twice that with venlafaxine. The safety profile and patient acceptability of venlafaxine are comparable to those of third-generation antidepressants, and possibly better than those of first-generation agents.
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PMID:Safety and tolerance profile of venlafaxine. 762 13

The antidepressant efficacy and safety of venlafaxine was shown previously in 6-week, placebo-controlled trials. We evaluated the long-term safety and clinical acceptability of venlafaxine and imipramine in a double-blind, parallel-group, comparative study. Two hundred ninety depressed outpatients were treated with venlafaxine, and an additional 91 received imipramine for as long as clinically necessary, up to 1 year. The total daily dose of each drug could vary from 75 to 225 mg. The Clinical Global Impressions Scale and a therapeutic response rate that was based on Clinical Global Impressions Scale-Improvement and incorporated discontinuation information were used to evaluate efficacy. Safety determinations and patient subjective ratings were used to evaluate safety and clinical acceptability. During the study, the adverse events were generally mild to moderate and most subsided with continued treatment; the most frequent were nausea for venlafaxine and dry mouth for imipramine. The anticholinergic side effect burden was significantly higher in the imipramine group than in the venlafaxine group. Venlafaxine was judged significantly more acceptable than imipramine, on the basis of the subjective ratings by patients. Fewer venlafaxine-treated patients than imipramine-treated patients withdrew because of adverse events and unsatisfactory response. There was a consistent trend in the therapeutic response rates in favor of venlafaxine that reached statistical significance at months 2, 6, and 12. In this long-term study, patient acceptability was greater for venlafaxine than for imipramine, suggesting therapeutic advantages for venlafaxine in the long-term treatment of depression. Additional studies with other active comparators are underway to confirm and extend these encouraging results.
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PMID:Long-term safety and clinical acceptability of venlafaxine and imipramine in outpatients with major depression. 780 87

The pharmacology, pharmacokinetics, and clinical efficacy of venlafaxine hydrochloride, a new antidepressant, are described. Venlafaxine inhibits the reuptake of serotonin, norepinephrine, and, to a lesser extent, dopamine. In animal models, it does not significantly inhibit muscarinic, histaminic, or adrenergic receptor activity and does not inhibit monoamine oxidase. Venlafaxine is rapidly absorbed and metabolized in the liver to its active metabolite, O-desmethylvenlafaxine (ODV). Time to peak concentration is one to two hours for the parent compound and four to five hours for ODV. The pharmacokinetics of venlafaxine might be dose-dependent, although pharmacokinetic studies have had conflicting results. The major route of elimination is renal; thus, patients with renal dysfunction may require lower doses. In double-blind, placebo-controlled trials of venlafaxine for maintenance therapy, venlafaxine has shown effective antidepressant activity in severely ill patients with major depression. Antidepressant effectiveness may be apparent within two weeks; this finding needs to be replicated. The dosage is 75-375 mg/day administered in two or three divided doses. The strength of the antidepressant response may be correlated with increasing dosage. Nausea is the most commonly reported adverse drug reaction (ADR). Others include somnolence, dizziness, dry mouth, and sweating. All ADRs have commonly occurred at the beginning of therapy and decreased with time. Overall, venlafaxine is well tolerated. Venlafaxine is as effective as other available antidepressants. It may cause fewer anticholinergic, antihistaminic, and antiadrenergic ADRs and may have a quicker onset of therapeutic action than existing antidepressants.
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PMID:Venlafaxine: a heterocyclic antidepressant. 755 8

The antidepressant venlafaxine has a unique chemical structure and neuropharmacologic profile. It significantly inhibits reuptake of both serotonin and norepinephrine and lacks notable muscarinic-cholinergic or alpha-adrenergic effects. Premarketing studies involving more than 2000 patients showed the efficacy of venlafaxine to be significantly greater than placebo at dosages between 75 and 375 mg/day in both outpatients and inpatients. The medication may be administered twice or three times daily. Venlafaxine was found equally effective for patients older and younger than 60 years and in those with psychomotor retardation or agitation; it proved slightly more efficacious than fluoxetine in a comparison study with melancholic inpatients. A promising finding of these studies is the suggestion of a rapid onset of clinical effect for venlafaxine. In some studies, venlafaxine showed a consistent and robust clinical superiority over placebo by Week 1, and in the inpatient study involving melancholic patients, the superiority of venlafaxine was demonstrated as early as Day 4. In general, early responses are seen at the higher dosages. Venlafaxine has also shown promise in treating rigorously defined treatment-refractory depression. The adverse effects of venlafaxine that most often led to discontinuation from a clinical study were nausea (6%), somnolence (3%), insomnia (3%), and dizziness (3%). Although nausea was the most common adverse effect overall, it resolved rapidly--within the first 1 to 3 weeks of therapy. Other adverse events with incidences significantly higher than with placebo were dizziness, constipation, sweating, nervousness, and abnormal ejaculation. The seizure rate and potential for cardiac conduction changes or orthostatic hypotension with venlafaxine were comparable with rates seen with the serotonin selective reuptake inhibitors. A small number of patients experienced dose-dependent blood pressure elevation with venlafaxine in premarketing studies (3% to 5% of those receiving < or = 200 mg/day; 7% of those receiving 201-300 mg/day; 13% of those receiving > 300 mg/day vs. 2% receiving placebo). In general, venlafaxine is well tolerated, and its treatment discontinuation rate is similar to those of the newer antidepressants and superior to discontinuation rates with the first-generation agents.
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PMID:The role of venlafaxine in rational antidepressant therapy. 796 45

Major depression is a common and disabling disorder with far-reaching social and economic implications. Nonetheless, major depression is treatable by one of the many currently available antidepressants with response rates of approximately 65-70%. Treatment of depression has improved in recent years because of the availability of effective and well-tolerated antidepressants, such as the selective serotonin reuptake inhibitors (SSRIs). The currently available antidepressants are generally equally effective and are distinguished primarily by side-effect profiles. The side effects of tricyclic antidepressants (TCAs) are attributed to their nonspecific interaction with cholinergic, histaminergic, serotonergic, and dopaminergic receptors in the central nervous system. The secondary amine TCAs, nortriptyline and desipramine, are preferred among the TCAs because of a more favorable side-effect profile. The TCAs are cardiotoxic, and overdoses are frequently fatal. Adverse effects, including potentially fatal drug and food interactions, limit the use of the monoamine oxidase inhibitors (MAOIs); however, these agents have a role in the treatment of depression with comorbid anxiety, refractory depression, atypical depression, and bulimia. The SSRIs possess a class side-effect profile of headache, nausea, and sexual dysfunction. Individual differences in side effects may distinguish fluoxetine (nervousness, restlessness), sertraline (diarrhea, loose stools), and paroxetine (dry mouth). The SSRIs all inhibit certain cytochrome P450 isoenzymes involved in the metabolism of drugs, such as the TCAs, and each SSRI has been reported to increase plasma concentrations of concomitantly administered TCAs. Bupropion therapy is associated with a risk of seizure development, which can be minimized by multiple daily doses. Trazodone is sedating and can rarely cause priapism. The related compound, nefazodone, does not cause sexual dysfunction or priapism, but is associated with sedation. Venlafaxine, a recently available antidepressant that appears to have efficacy in treatment-refractory depression, may cause nausea that requires gradual upward dosage titration. Higher doses of venlafaxine may also cause elevations in blood pressure, heart rate, and serum cholesterol. As more is learned about the pathophysiology of depression, even more specific and well-tolerated antidepressants will be developed.
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PMID:Contemporary management of depression. 799 23

A double-blind, placebo-controlled trial was undertaken to compare the safety and efficacy of venlafaxine and trazodone in patients with major depression. Two hundred twenty-five patients entered an initial 6-week treatment phase, and 149 completed it. Ninety-six patients who were responders continued in a 1-year, double-blind, long-term phase during which they received the same medication and doses they had during the short-term phase. Both active treatments were significantly more effective than placebo on some measures during the short-term study, but venlafaxine produced more improvement in the cognitive disturbance and retardation factors on the Hamilton Rating Scale for Depression. Trazodone was more effective against the sleep disturbance factor. Patients on venlafaxine were most likely to enter the long-term phase and to remain in the trial longest. The side effect profiles of the three treatment groups were compared. Venlafaxine was most likely to cause nausea, whereas trazodone was associated with the most dizziness and somnolence.
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PMID:A comparison of venlafaxine, trazodone, and placebo in major depression. 819 64

In this study, 312 depressed outpatients received either placebo or one of three venlafaxine doses twice daily (b.i.d.) for up to 6 weeks. The total daily doses of venlafaxine were 25, 50-75, and 150-200 mg/day. Hamilton Rating Scale for Depression (HAM-D) and Montgomery-Asberg Depression Rating Scale (MADRS) total scores at Week 6 were significantly lower for the high-dose group than for the placebo group. A positive dose-response trend for the primary efficacy parameters was demonstrated as early as Week 1. Venlafaxine was well tolerated at all dose levels. The most common side effects of clinical interest were nausea and dry mouth. The frequency of nausea in the venlafaxine groups was essentially the same (25-29%), whereas the frequencies of dry mouth, somnolence, and sweating were dose related. The results indicate that b.i.d. doses of venlafaxine are safe and effective in treating depression.
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PMID:Efficacy and safety of b.i.d. doses of venlafaxine in a dose-response study. 829 Jun 61

Major depression is a debilitating disorder that is often undertreated. Psychotherapy, electroconvulsive therapy, and pharmacotherapy are options for management. Tricyclic antidepressants and selective serotonin reuptake inhibitors are the cornerstones of drug therapy. Venlafaxine, a phenylethylamine antidepressant that primarily inhibits reuptake of norepinephrine and serotonin, is an alternative to those agents. It has been studied in short-term and continuation studies and appears to have efficacy similar to that of imipramine, trazodone, and fluoxetine. Moreover, venlafaxine is effective in approximately one-third of patients with treatment-resistant depression. Venlafaxine is metabolized by the P-450 enzyme system to an active metabolite O-desmethyl-venlafaxine, which is excreted renally. Nausea, somnolence, and dizziness are dose-related adverse effects that often occur with initiation of therapy. Increases in blood pressure, particularly with high dosages, also may occur. Drug-drug interactions appear to be minimal.
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PMID:Therapeutic options for treating major depression, and the role of venlafaxine. 872 93


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