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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A double-blind, placebo-controlled, randomized trial was carried out to compare the efficacy and tolerability of paroxetine in outpatients with moderate to moderately severe depression without mania. Paroxetine was found to be an effective antidepressant drug when compared to placebo. For most of the measures of efficacy the benefit appeared after two weeks of therapy, but sleep was improved after one week. Patients taking paroxetine complained of more adverse effects than those on placebo; they were mainly gastrointestinal with nausea the most commonly reported.
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PMID:A double-blind comparison of paroxetine and placebo in the treatment of depressed outpatients. 143 Oct 7

Paroxetine is a new selective serotonin reuptake inhibitor which has been extensively evaluated as an antidepressant in clinical trials and a large computerized safety database has been accumulated. A comprehensive review of data on dosage supports the recommendation that 20 mg paroxetine daily is the optimal therapeutic dose for most patients. When compared to active controls--mainly tricyclic antidepressants--paroxetine was found to have a different adverse-event profile with fewer anticholinergic, cardiovascular and nervous system events but more gastrointestinal events, particularly nausea. However, these events were not severe and did not usually lead to discontinuation of treatment. The adverse events reported with paroxetine were most likely to occur early in the course of treatment and there was no evidence of any increase in events in the elderly or with longer-term treatment. Paroxetine was not associated with excess of death from any cause, suicides, suicide attempts or serious life-threatening events. No clinically significant drug-related abnormalities were reported in laboratory monitoring, including liver function tests, in short- or long-term use. Finally, and importantly for an antidepressant, paroxetine appears relatively safe in overdose.
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PMID:Paroxetine: an overview of dosage, tolerability, and safety. 143 Oct 15

The pharmacology and pharmacokinetics, adverse effects, drug interactions, efficacy, and dosage and administration of the new selective serotonin reuptake inhibitors paroxetine, sertraline, and fluvoxamine are reviewed. Paroxetine, sertraline, and fluvoxamine all have large volumes of distribution and are highly bound to plasma proteins. In contrast to fluoxetine, these three drugs possess shorter elimination half-lives of approximately one day and are metabolized to clinically inactive compounds. Nausea was the most commonly reported adverse effect for all three agents. Other reported adverse effects are headache, sedation, dry mouth, insomnia, sexual dysfunction, and constipation. Because of their favorable pharmacokinetic profiles, paroxetine, sertraline, and fluvoxaetine are less likely than fluoxamine to interact with other drugs. Paroxetine has been found to be superior to placebo and equivalent to amitriptyline, imipramine, clomipramine, and doxepin in treatment of depression. Sertraline has been found to be superior to placebo and equivalent to amitriptyline in treatment of depression. Fluvoxamine has been found to be superior to placebo and equivalent to imipramine, clomipramine, desipramine, mianserin, and maprotiline in the treatment of depression. Fluvoxamine and sertraline have been shown to be superior to placebo in the treatment of obsessive-compulsive disorder. Clinical experience has demonstrated all three drugs to be effective in treatment of depression. They may be especially useful in elderly patients, in those who cannot tolerate alternative treatments, and in those who do not respond to adequate trials of other antidepressant therapies.
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PMID:Paroxetine, sertraline, and fluvoxamine: new selective serotonin reuptake inhibitors. 146 19

Paroxetine is a novel phenylpiperidine compound that acts as a selective serotonin reuptake inhibitor (SSRI). It is a more selective and potent SSRI than fluoxetine, sertraline, or fluvoxamine. Its pharmacokinetics are well suited to clinical use. Its half-life is approximately 24 hours, and it has no active metabolites. As with other SSRIs, there are few clinically significant drug interactions with paroxetine. Clinical studies consistently show that paroxetine alleviates moderate or severe depression and associated anxiety. It begins to act at least as rapidly as the tricyclic antidepressants. Animal data and limited human experience suggest relative safety in overdose and no evidence of teratogenicity. As with other SSRIs, the most common side effect of paroxetine is nausea, which is usually well tolerated. The nausea rarely leads to drug discontinuation or even dosage reduction. Little weight loss or weight gain occurs with paroxetine at doses used to treat depression, and the drug has no effect on the seizure threshold. Unlike other SSRIs, paroxetine has a relatively low incidence of anxiety and agitation. There is no evidence that paroxetine increases suicidal ideation. This supplement will contribute several important new papers to the literature on paroxetine.
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PMID:An overview of paroxetine. 153 19

Considerable research shows that serotonin dysfunction is implicated in major depression. Paroxetine is an investigational antidepressant that appears to act by selectively blocking neuronal serotonin uptake. Seventy-two outpatients with moderate-to-severe major depression entered this 6-week, double-blind comparison of paroxetine and placebo. The results showed clear and significant superiority of paroxetine on all of the major outcome variables. These included physician-rated measures such as the Hamilton Rating Scale for Depression and its four factor scores, the Clinical Global Impressions scale, the Montgomery and Asberg Depression Rating Scale, and the Raskin Depression Scale. Results on these agreed well with patient-rated measures like the Hopkins Symptom Checklist and Patient Global Evaluation Scale. Paroxetine was also very well tolerated. Nausea and constipation occurred significantly more often with paroxetine, but only 9% of paroxetine patients dropped out of the study due either in whole or in part to an adverse effect. This compares to 8% of the placebo patients who were discontinued for the same reason. This study suggests that paroxetine is a safe and effective medication for the treatment of major depression.
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PMID:The safety and efficacy of paroxetine compared with placebo in a double-blind trial of depressed outpatients. 153 21

Depressive illness among the elderly is an important public health concern. However, treatment of the elderly may be complicated by age-related changes in physiology, general medical status, and susceptibility to side effects. There is therefore a need for improved treatment modalities for depressed elderly patients. Paroxetine is an antidepressant that acts through selective inhibition of serotonin reuptake. It lacks the anticholinergic and cardiovascular side effects of most first- and second-generation antidepressants. The authors present the combined data from two similarly designed comparisons of paroxetine and doxepin in outpatients over 60 years of age with major depression. The results show that paroxetine was an effective as doxepin in alleviating depression as measured on the Hamilton Rating Scale for Depression (HAM-D) total score, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Hopkins Symptom Checklist (SCL) depression factor score. Paroxetine was significantly superior to doxepin on the Clinical Global Impressions (CGI) scale for severity of illness, the HAM-D retardation factor, and the HAM-D depressed mood item. Doxepin produced significantly more anticholinergic effects, sedation, and confusion. Paroxetine was associated with more reports of nausea and headache. These results suggest that paroxetine may be a valuable tool for the treatment of major depression in the elderly.
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PMID:Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression. 153 27

Side effects remain one of the most important clinical issues in antidepressant therapy. Patients may not be able to take appropriate treatment or may not tolerate their medication in adequate doses or for an adequate length of time to manage their depressive illness. This article reviews the extensive safety data from 6705 patients treated with paroxetine. These data indicate that paroxetine has no significant cardiovascular effects, few significant drug interactions, and no clinically significant effects on the ECG or EEG. Furthermore, paroxetine is relatively safe in overdose and has very little anticholinergic activity. Psychomotor performance is not impaired by paroxetine and there is no evidence of any zimelidine-like hypersensitivity reactions or increase in suicidal ideation. As with other selective serotonin reuptake inhibitors (SSRIs), the most common side effect is gastrointestinal upset, especially nausea. This is usually very well tolerated and rarely leads to drug discontinuation. As with other SSRIs, monoamine oxidase inhibitors should not be prescribed concurrently or soon after discontinuing paroxetine because of the risk of a lethal interaction. Paroxetine may be less likely than currently available SSRIs to cause agitation. In general, paroxetine has a very favorable side effect profile and should be an important alternative in the medical treatment of depressive illness.
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PMID:The safety profile of paroxetine. 153 28

Paroxetine is a potent and selective inhibitor of the neuronal reuptake of serotonin, thereby facilitating serotoninergic transmission; this action appears to account for the antidepressant activity observed with this drug. A mean terminal elimination half-life of approximately 24 hours permits once daily administration. Results of short term clinical trials have shown paroxetine to be significantly superior to placebo, and comparable to amitriptyline, clomipramine, imipramine, dothiepin and mianserin in relieving symptoms associated with major depressive disorders. Paroxetine has shown some preliminary promise in the treatment of depressive illness resistant to tricyclic antidepressant therapy but further studies are required before any conclusions can be drawn. Paroxetine in therapeutic doses has been very well tolerated, and the favourable tolerability profile of this agent appears to be its primary advantage over traditional antidepressant agents. Paroxetine causes minimal anticholinergic-type adverse effects, and unlike tricyclic antidepressants, it does not precipitate cardiovascular effects or provoke cardiac conduction disturbances. Nausea has been the most frequently reported adverse event during short term use of paroxetine, but it is generally mild and transient and subsides with continued use. With longer term use headache, sweating and constipation were the most frequently reported side effects but the incidence rate was not significantly different from that noted for comparator antidepressants. Furthermore, the frequency of withdrawal due to adverse effects is less with paroxetine than with tricyclic antidepressant agents. Overall, available data appear to indicate that while the efficacy of paroxetine is similar to that of traditional antidepressant drugs, the newer agent possesses much improved tolerability. In addition, the wide therapeutic index of paroxetine may be beneficial when treating patients with an increased risk of suicide. Thus, paroxetine clearly looks to become a valuable addition to the range of drugs currently available to treat depressive illness. Future research may help to further define the relative place of this newer agent in antidepressant therapy and determine how its overall therapeutic efficacy compares with that of other related antidepressant agents such as fluoxetine.
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PMID:Paroxetine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depressive illness. 170 52

Paroxetine is a novel antidepressant drug with selective serotonin (5-HT) reuptake inhibitory properties. In a double-blind placebo-controlled crossover sleep laboratory study the single-dose effects on objective and subjective sleep and awakening qualities were investigated after paroxetine 20, 30 and 40 mg morning doses (PX 20, 30, 40), paroxetine 30 mg evening dose, fluoxetine 40 mg morning dose (FX 40) and placebo in 18 healthy young volunteers. The drugs were orally administered in 2-wk intervals. In addition to each drug night, the adaptation night and washout night were recorded. Polysomnographic investigations (10:30 p.m. to 6:00 a.m.) showed a delayed sleep onset only after the morning intake of paroxetine, PX 40 being statistically different from placebo. Total sleep time and sleep efficiency deteriorated under morning PX 30, PX 40 and evening PX 30 as compared to placebo. The nocturnal wake time and sleep stage 1 increased under the paroxetine. Rapid eye movement (REM) reduction (min and %) occurred dose dependently after all paroxetine doses, but the REM latency was lengthened only after the morning intake. The suppressant effect on REM sleep is characteristic for antidepressants and was still significant in the washout nights following PX 40 and evening PX 30. The only statistically relevant finding under 40 mg fluoxetine referred to the increase of REM latency in both drug and washout nights. In contrast to objective results, subjective sleep quality remained generally unchanged. Attention, concentration and reaction performance improved under paroxetine as compared to baseline. The deterioration of well-being under PX 40 might be related to the appearance of drowsiness and nausea. Blood pressure and pulse rate were unaffected.
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PMID:Sleep laboratory studies on the single-dose effects of serotonin reuptake inhibitors paroxetine and fluoxetine on human sleep and awakening qualities. 183 94

Paroxetine is a new antidepressant drug. It is a potent and selective 5-HT re-uptake inhibitor with only weak anticholinergic properties and less effect on the cardiovascular system than the classical tricyclics. In this double-blind multicenter study the antidepressant effect of paroxetine was compared with mianserin in 70 patients with unipolar or bipolar depression. Each drug was administered for 6 weeks after a 1 week run-in period at a daily dosage of 30 mg for paroxetine or 60 mg for mianserin. The 21-item Hamilton Depression Rating Scale (HAM-D) and the physician's global assessment were used to assess efficacy. Both treatment groups showed statistically significant improvement of the HAM-D at Weeks 1 (base-line values: paroxetine mean 28.5; mianserin mean 30.8) through to Week 6 (paroxetine mean 11.5; mianserin mean 17.8) (P less than 0.06). The endpoint differences between treatments however were not statistically different (P = 0.11). The Cleary and Guy factor analysis showed a significant difference (P less than 0.03) at Weeks 2 and 4 for cognitive disturbance and at Weeks 4 and 6 for retardation in favour of paroxetine compared with mianserin. Both drugs were well tolerated with nausea and headache in four patients and somnolence in six patients being reported as the most common side-effect for paroxetine and mianserin respectively.
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PMID:Paroxetine in the treatment of depression. A double-blind multicenter study versus mianserin. 297 Feb 3


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