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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

Three 6-8 week comparative studies have shown sertraline to be an effective, safe and well-tolerated treatment for acute depressive illness. The first, a double-blind fixed-dose study, demonstrated the efficacy of sertraline over placebo; the second, a forced upward titration, active- and placebo-controlled, double-blind study, showed that sertraline was of equal efficacy to amitriptyline. The third was a double-blind comparison of sertraline and amitriptyline in elderly depressives, with the dose being increased as necessary and as tolerated. The overall results showed sertraline to be consistently superior to placebo and equivalent in therapeutic effect to amitriptyline on a number of measures including depression, anxiety, insomnia and suicidal ideation. Efficacy was found in both moderately and severely depressed patients whose primary psychiatric diagnoses included single-episode and recurrent major depression, with and without melancholia. Sertraline was also found to be effective in patients with a high baseline anxiety score on the Hamilton Rating Scale for Depression.
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PMID:Controlling acute episodes of depression. 180 27

Two hundred forty-one elderly depressed patients entered the 8-week, double-blind phase of this parallel-group, multicenter study; 161 patients were randomized to receive sertraline (50-200 mg/day) and 80 were randomized to receive amitriptyline (50-150 mg/day). Among evaluable patients, there were no statistically significant differences between treatments in any of the primary efficacy variables: change in total Hamilton Rating Scale for Depression (HAM-D) score (17 items), percentage change in HAM-D score, change in HAM-D Item 1, change in Clinical Global Impressions (CGI) Severity score, change in the Depression Factor of the 56-item Hopkins Symptom Checklist, and the CGI Improvement score at the last visit. Similar results were obtained using data from all patients (intention-to-treat analysis), except that amitriptyline was superior in HAM-D Total score (p = .044). The two drugs produced a similar degree of response: on the basis of the HAM-D criterion, 69.4% of sertraline patients and 62.5% of amitriptyline patients responded, and, on the basis of CGI criterion, 79.5% of sertraline and 73.4% of amitriptyline patients responded. Twenty-eight percent of the sertraline patients withdrew from the study because of a treatment-related side effect and 2.5% (4) because of a laboratory abnormality. In comparison, 35% of the amitriptyline patients withdrew because of treatment-related side effects. Sertraline was associated with a statistically lower frequency of somnolence, dry mouth, constipation, ataxia, and pain and a higher frequency of nausea, anorexia, diarrhea/loose stools, and insomnia; thus, anticholinergic effects were less common and gastrointestinal effects were more common with sertraline than with amitriptyline.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients. 225 79

An eight-week double-blind, multicentre study was performed to evaluate the efficacy and safety of sertraline vs. fluoxetine in the treatment of major depression (DSM-III-R). There were 108 out-patients, from nine Italian centres, entered into the study, of whom 88 were evaluable (48 sertraline, 40 fluoxetine). The final mean daily dose of sertraline was 72 mg and for fluoxetine it was 28 mg. Both treatment groups showed a statistically significant improvement from baseline at one week, and this was maintained until the end of treatment for all of the following measures: Hamilton Rating Scales for Depression and Anxiety, the Montgomery Asberg Depression Rating Scale, Clinical Global Impressions Scale, Zung Self-Rating Scale for Anxiety and the Leeds Sleep Evaluation Questionnaire. Although there was a numerical advantage for sertraline on several efficacy measures, there was no statistically significant difference found between the treatment groups. The incidence of adverse events was similar for both treatments; 40.4% for sertraline and 39.3% for fluoxetine. However, adverse events were generally rated by patients as of lower severity in the sertraline group. In addition, for the fluoxetine group, there was a higher incidence of agitation, anxiety and insomnia than for sertraline. Sertraline was considered to be better tolerated than fluoxetine overall, since only 9.6% of sertraline-treated patients discontinued treatment due to therapy failure whereas in the fluoxetine-treated group this figure was 19.6%. By contrast, 13.5% of sertraline-treated patients discontinued prematurely because of clinical improvement, compared with 10.7% of fluoxetine-treated patients.
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PMID:Double-blind study of the efficacy and safety of sertraline versus fluoxetine in major depression. 826 18

This open study investigated the effects of sertraline in treating 13 adolescents, ages 12 to 18, who were hospitalized for treatment of a major depressive episode. The sample included 7 adolescents with nonendogenous depression and 6 with endogenous depression, as diagnosed by both Research Diagnostic Criteria (RDC) and Kiddie-SADS-P DSM-III-R endogenous subtype criteria. These patients were followed for an inpatient length of stay ranging from 9 to 38 days (mean 19 days), with later outpatient follow-up for a total of 12 weeks. Measures of depression were found to improve significantly, including suicidal ideation and most of the DSM-III-R symptoms of major depression. Sertraline (mean 110 mg or 1.96 mg/kg daily) significantly decreased scores on the 24-item Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale from premedication baseline to treatment week 12, and also between weeks 1 (after a large week 1 improvement, presumably due to nondrug effects) and 12. There was a small but significant improvement on the Children's Global Assessment Scale between baseline and week 12, but the Family Global Assessment Scale showed no significant change; neither global assessment scale showed significant effects between weeks 1 and 12. Sleep disturbance was common (69%) after 12 weeks of treatment, but clinically significant improvements in sleep patterns were also observed. This open-label prospective study suggests that sertraline might be useful in treating adolescents with major depression. Adverse effects, mainly insomnia and drowsiness, were relatively common but usually manageable. One patient developed mania after 8 days of sertraline treatment at a dose of 100 mg daily.
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PMID:An open study of the effects of sertraline on adolescent major depression. 923 Dec 98

(1) The choice of treatment for children with obsessive-compulsive disorder is difficult. Behaviour therapy and antidepressants have not been assessed adequately in this setting, and their efficacy seems limited. Clomipramine was the first antidepressant to show a degree of efficacy. (2) Sertraline is the first drug to be licensed in France for children aged from 6 to 17 years with obsessive-compulsive disorder. (3) According to our literature search, the evaluation file on sertraline in this indication mainly contains data from a double-blind placebo-controlled trial involving 187 children. After 3 months of treatment, sertraline was significantly more effective than placebo, although most children remained symptomatic. Direct comparison is lacking, but sertraline seems as effective as clomipramine. (4) However, 13% of children receiving sertraline left this trial because of adverse events (3% on placebo; p = 0.02). The short-term safety profile of sertraline in children is the same as in adults, i.e. mainly nausea, agitation, headache, insomnia and tremor. (5) We have no data on the effects of prolonged sertraline therapy in children, particularly on neuropsychological development. (6) The first-line treatment of obsessive-compulsive disorder is behaviour therapy. Sertraline, like clomipramine, is an option when behaviour therapy fails or is unfeasible. The choice between sertraline and clomipramine should be discussed case by case, according to their safety profiles; however, we have more experience with clomipramine, which should therefore be preferred over sertraline.
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PMID:Sertraline: new indication. May help children with obsessive-compulsive disorder. 1206 39

In a double-blind multicentre study of outpatients with DSM-III-R major depressive disorder, 129 sertraline and 129 placebo patients were evaluated over a 6-week period. Sertraline exhibited a significantly greater (P < 0.001) antidepressant effect compared to placebo as measured by the HAM-D, MADRS, CGI-S and CGI-I. In the subset of patients with severe depression (baseline HAM-D >/= 25), sertraline was also significantly more effective than placebo (P < 0.05). Side effects were more commonly reported in sertraline (59%) compared to placebo (38%) patients; the most common being nausea, headache and insomnia. A subset of 107 patients (66 sertraline; 41 placebo) who were defined as responders (CGI-I of 1 or 2) after 6 weeks treatment were entered into a 20-week continuation phase. In this responder subset, there was continuing improvement in both groups of patients, but with no significant differences in mean HAM-D or MADRS between the groups. However, a higher number of sertraline patients were associated with a persistent pattern of improvement relative to placebo (P < 0.05). The incidence of side effects was similar in sertraline (52%) and placebo (49%) treated patients in the continuation period.
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PMID:A double-blind placebo-controlled multicentre study of sertraline in the acute and continuation treatment of major depression. 1969 3

We report a 75-year-old woman developing serotonin syndrome following minimum doses of sertraline. She showed a depressed mood, insomnia, and general fatigue and was taking sulpiride at 300 mg/day, alprazolam at 1.2 mg/day, zopiclone at 7.5 mg/day, and etizolam at 1 mg/day. As she remained symptomatic, sertraline at 25 mg/day was added. Within 14 hours of starting sertraline, the patient began to experience delirium, impaired coordination, diaphoresis, tremulousness of the upper limbs bilaterally, and agitation. Sertraline was thus discontinued, and all of the above-mentioned symptoms disappeared rapidly. Serotonin syndrome is rarely reported in patients taking sertraline in Japan. To our knowledge, ours is the second case of serotonin syndrome associated with sertraline in Japan. According to Drug in Japan, sertraline must be started at the lowest efficacious dose with slow titration and is contraindicated for patients who are taking pimozide or monoamine oxidase inhibitors (MAOIs). Also, the coadministration of sertraline with other agents such as lithium, tricyclic antidepressants, and triptans necessitates the close observation of symptoms and signs. However, our case didn't take any of these combinations, and she was administered 25 mg/day, the lowest efficacious dose. This report emphasizes that caution is needed when prescribing sertraline to elderly patients and on its coadministration.
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PMID:[A case of serotonin syndrome following minimum doses of sertraline]. 1999 61

Sertraline is a selective serotonin reuptake inhibitor with established safety for the treatment of depression. Among the common adverse effects associated with sertraline are nausea, insomnia, diarrhea, somnolence, and dizziness. Cardiac arrest had not been reported in the literature, although tachycardia was frequently seen. In this case report, a patient was presented who had adverse reactions such as nausea, dizziness, insomnia under citalopram treatment, and after his drug was changed to sertraline, developed sinus arrest on the fourth day of treatment.
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PMID:Sinus arrest due to sertraline. 2055 30

Sertraline, a novel selective serotonin re-uptake inhibitor, has been proven as effective as amitriptyline and imipramine, and more effective than placebo, in double-blind controlled studies in patients with major depressive disorder. The question 'Do symptoms predict response to treatment?' is an important one in clinical practice. In order to try and answer this question, four double-blind clinical trials in major depressive disorder have been examined for clinically important symptoms and subgroups at entry to the studies. The Hamilton Depression Rating Scale (HAM-D, 17-item) was used throughout and the data for sertraline-treated patients were split in several different ways. The response to treatment was defined as the percentage of patients achieving a CGI-improvement score of 1 or 2 at the end of treatment. Patients with severe depression at entry had a response rate of > 80%, which was comparable to that of patients with moderate depression. A similar response rate was seen in the presence of DSM-III-defined melancholia, high anxiety, insomnia, psychomotor agitation or retardation. Finally, in order to examine the effect of old age on the response to treatment, one of the four studies, which included only patients aged 65 or older, was examined separately. In this study responders were defined as those with >50% reduction in baseline HAM-D at the end of treatment. Approximately 70% were found to be responders in both the moderate and severe depression subgroups.
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PMID:Symptoms as predictors of response in depression. 2228 66


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