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Biomedical subjects

J P Feighner

Publications and source records attributed to J P Feighner.

At least 19 recordsLinked to original sources
PubMed1992

A double-blind comparison of paroxetine, imipramine and placebo in depressed outpatients.

Diagnostic criteria, random parallel placebo-controlled study design, and appropriate clinical assessment for both safety and efficacy are all among the essential requirements for the evaluation of a new antidepressant agent. Paroxetine and imipramine were compared for efficacy and safety in a large multicentre, randomized, placebo-controlled, double-blind, parallel design study in the USA. The study involved 717 outpatients with major depressive disorder; after a one-week washout period they were treated for 6 weeks, being assessed at weekly intervals. The results from all six participant centres combined showed that both active drugs were statistically superior to placebo by week 2 and that the antidepressant response was significant for both. Paroxetine was better tolerated than imipramine with fewer dropouts from side effects. This combined study clearly indicated that paroxetine was an effective and well-tolerated antidepressant.

Adult↗
PubMed1992

An overview of paroxetine.

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.

Antidepressive Agents↗
PubMed1992

Paroxetine in the treatment of depression: a comparison with imipramine and placebo.

Paroxetine is a selective serotonin reuptake inhibitor with significant antidepressant properties. This was a 6-week placebo- and imipramine-controlled study of 120 outpatients with major depression. Paroxetine was statistically significantly superior to placebo on almost all outcome measures. This was apparent as early as 1 week. Paroxetine was also significantly superior to imipramine on the Hamilton Rating Scale for Depression total score. Paroxetine was generally better tolerated than imipramine. These results strongly support paroxetine's effectiveness in the treatment of major depression and suggest that paroxetine will be a valuable addition to the options in treating depressive illness.

Adolescent↗
PubMed1992

Two combined, multicenter double-blind studies of paroxetine and doxepin in geriatric patients with major depression.

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.

Age Factors↗
PubMed1991

A comparison of paroxetine, imipramine and placebo in depressed out-patients.

To compare the safety and antidepressant efficacy of paroxetine, imipramine, and placebo, data from six centres using the same protocol were pooled. A double-blind parallel-group design was used, with therapy lasting six weeks. From week 2 onwards, both the 240 paroxetine-treated and the 237 imipramine-treated patients were significantly different from the 240 placebo-treated patients, but no different from each other. Side-effects with paroxetine were less likely to lead to drop-out than with imipramine. Paroxetine had a possible earlier antidepressant effect than imipramine, and a possible earlier beneficial effect on anxiety symptoms associated with depression.

Adult↗
PubMed1991

A 102-center prospective study of seizure in association with bupropion.

BACKGROUND: This trial was conducted to determine the incidence of seizures associated with the use of bupropion. METHOD: A total of 3341 depressed patients from 102 sites were enrolled in this 8-week, prospective, open trial. Following the 8-week treatment phase, patients could elect to enroll in a humanitarian continuation phase of unlimited duration. Dosing was initiated at 225 mg/day and increased to 450 mg/day as tolerated. Investigators carefully monitored seizure occurrences and rated their patients' response to and tolerance of bupropion. RESULTS: A total of 1986 patients (61%) completed the 8-week treatment phase, and 1616 (81%) of these elected to be maintained on bupropion treatment in the humanitarian continuation phase. The observed seizure rate was 0.24% for the treatment phase and 0.40% for the entire study. An 8-week survival analysis performed on patients with a dosing regimen of 300 to 450 mg/day yielded a cumulative rate of 0.36%. Patients, including those previously resistant to antidepressant treatment, responded to and tolerated bupropion well. CONCLUSION: These rates confirm earlier seizure estimates and fall within accepted parameters for antidepressant drugs. This trial enhances bupropion's position as a valuable alternative for the management of depression.

Adolescent↗
PubMed1991

Double-blind comparison of bupropion and fluoxetine in depressed outpatients.

BACKGROUND: This study was undertaken to compare the efficacy and safety of bupropion and fluoxetine. METHOD: Moderately to severely depressed outpatients who fulfilled the DSM-III-R criteria for nonpsychotic major depressive disorder and had a score of 20 or more on the Hamilton Rating Scale for Depression (21 item) participated in this two-center study. Following a 1-week placebo phase, patients were randomly assigned to receive either bupropion or fluoxetine for 6 weeks of double-blind treatment. Weekly efficacy assessments included Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Clinical Global Impressions-Severity, and Clinical Global Impressions-Improvement. Vital signs and adverse experiences were also assessed weekly. RESULTS: A total of 61 patients were randomly assigned to receive bupropion (225-450 mg/day) and 62 were randomly assigned to receive fluoxetine (20-80 mg/day). The mean daily dose at the end of the study was 382 mg/day for the bupropion treatment group and 38 mg/day for the fluoxetine treatment group. There were no statistically significant differences between treatments on any of the efficacy variables. On the basis of a 50% or greater reduction in the HAM-D scores, 63% (N = 37) of the bupropion-treated and 58% (N = 35) of the fluoxetine-treated patients were categorized as responders, and on the basis of CGI scores, 68% (N = 40) of the bupropion-treated and 58% (N = 35) of the fluoxetine-treated patients were rated as much or very much improved. HAM-A scores decreased by 59% for both treatment groups. The incidence of treatment-emergent adverse events was low with no statistically significant differences between treatments. Twenty-six percent (N = 16) of the bupropion-treated and 29% (N = 18) of the fluoxetine-treated patients prematurely discontinued treatment. CONCLUSION: Both bupropion and fluoxetine demonstrated similar efficacy in relieving depression and accompanying symptoms of anxiety, and both exhibited a similar, favorable safety profile.

Adult↗
PubMed1990

A controlled trial of adinazolam versus desipramine in geriatric depression.

Thirty outpatients between the ages of 60 and 85 with DSM-III Major Depression entered an 8 week randomized, double-blind comparison of desipramine and adinazolam mesylate, a triazolobenzodiazepine derivative. Outcome was assessed on several measures including the Hamilton Depression Rating Scale (HDRS), Montgomery-Asberg Rating Scale, Clinical Global Impressions (CGI), the 35-item Self-Rating Symptom Scale, and Carroll Depression Scale. Patients in both groups demonstrated a highly significant decrease in average HDRS scores (p less than 0.001) over the course of the study. Adinazolam was associated with significantly greater reduction in average HDRS scores by the third day. Repeated measures analysis of variance showed a significantly greater reduction in HDRS scores for adinazolam over the course of the study. The study medications were associated with distinct patterns of adverse reactions. Desipramine more often produced dry mouth, constipation and nervousness, while adinazolam was more likely to cause drowsiness and lightheadedness. Three of these elderly patients, all of whom were taking desipramine reported at least one fall during the study. Adinazolam may be a promising agent in the treatment of depression in the elderly.

Administration, Oral↗
PubMed1990

A fixed-dose (300 mg) efficacy study of bupropion and placebo in depressed outpatients.

Two hundred twenty-four outpatients with major depression entered a 6-week, five-center, double-blind trial of bupropion 300 mg/day and placebo. A total of 216 patients were included in the efficacy analysis. In the combined center analysis, greater efficacy for bupropion was found on one or more measures (Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, and Clinical Global Impressions) at treatment Days 21, 28, 35, and 42. Bupropion was well tolerated; only four adverse events were reported at least 5% more often in the bupropion group than in the placebo group. Six bupropion patients versus 5 placebo patients discontinued treatment because of adverse events. This study extends earlier findings of efficacy for higher-dose treatment in an inpatient population to lower-dose treatment in an outpatient population.

Adult↗
PubMed1990

Adverse consequences of fluoxetine-MAOI combination therapy.

The authors describe two series of patients: 12 treated simultaneously with fluoxetine and a monoamine oxidase inhibitor and 6 patients started on treatment with an MAOI 10 days or more after stopping fluoxetine treatment. All patients had extremely refractory depression and were treated in open fashion before general knowledge was obtained of the side effects that may accompany the fluoxetine-MAOI combination. During the fluoxetine-MAOI trial, most patients continued to receive other psychotropic combinations that had been partially helpful. The use of fluoxetine and an MAOI, either together or in close succession, was accompanied by a very high incidence of adverse effects, especially the "serotonergic syndrome." This syndrome was characterized by mental status changes, such as hypomania and confusion, and physical symptoms, such as myoclonus, hypertension, tremor, and diarrhea. Because of the high incidence of side effects and the lack of definite efficacy, the concurrent use of fluoxetine and MAOIs should generally be avoided. The long half-lives of fluoxetine and norfluoxetine, as well as the prolonged metabolic effects of MAOIs, may also dispose patients to an interaction if one of the drugs is started soon after stopping the other.

Adult↗
PubMed1989

A double-blind comparison of fluoxetine, imipramine and placebo in outpatients with major depression.

Fluoxetine is the first selective serotonin reuptake inhibitor antidepressant to be marketed in the U.S. In this double-blind trial fluoxetine was compared with imipramine and placebo among 198 outpatients with DSM-III major depression, of whom 145 completed at least 2 weeks of active treatment and were evaluated for efficacy. Significantly fewer patients in each active drug group terminated early due to lack of efficacy compared to placebo. Both imipramine and fluoxetine were significantly superior to placebo on most measures. There were no consistently significant differences between the two active drugs although a trend favored imipramine on a number of measures. Fluoxetine was generally well tolerated. Significantly more imipramine than placebo patients terminated early due to side-effects while the fluoxetine-placebo difference was not significant. The results support previous studies which suggest fluoxetine's superior side-effect profile and the approximate antidepressant equivalence of fluoxetine and TCAs.

Adult↗
PubMed1989

A placebo-controlled inpatient comparison of fluvoxamine maleate and imipramine in major depression.

Fluvoxamine, a selective serotonin reuptake inhibitor, was investigated in a 6-week double-blind study among severely ill inpatients with DSM-III major depression. All but 1 patient also fulfilled criteria for melancholia. Following a 3-day placebo wash-out patients were randomly assigned to fluvoxamine, imipramine or placebo. Sixty of 81 patients completed at least 2 weeks following wash-out and were evaluated for efficacy. Analysis of covariance (controlling for baseline scores) showed significant (p less than 0.05) differences on CGI severity and BPRS total and a similar trend (p = 0.08) on the Hamilton Depression Scale. Fluvoxamine was superior (p less than or equal to 0.02) to both placebo and imipramine on these measures. Fluvoxamine's most common adverse effects were nausea and agitation. The number of fluvoxamine patients withdrawn for side-effects was less than imipramine and not significantly different than placebo. Fluvoxamine was not associated with significant changes in vital signs, ECG or laboratory tests. The results therefore indicate that fluvoxamine is a safe and highly effective treatment for hospitalized patients with major depression.

Adolescent↗
PubMed1989

Paroxetine in the treatment of depression: a comparison with imipramine and placebo.

Paroxetine is a selective serotonin uptake inhibitor, which is being investigated as an antidepressant. In this double-blind, six-week study 120 outpatients with DSM-III major depression were randomly assigned to treatment with paroxetine, imipramine, or placebo. Results showed a statistically significant superiority of paroxetine over placebo on almost all outcome measures. Paroxetine was significantly superior to imipramine on the HAMD total score and was generally better tolerated than imipramine. The results support paroxetine's effectiveness in the treatment of major depression and suggest that further studies with this compound are warranted.

Antidepressive Agents↗
PubMed1989

Analysis of individual symptoms in generalized anxiety--a pooled, multistudy, double-blind evaluation of buspirone.

Pooled data for 427 patients with generalized anxiety disorders were analyzed retrospectively from six double-blind trials evaluating buspirone, a nonbenzodiazepine anxiolytic, in the treatment of generalized anxiety disorder. After a 4- to 7-day washout period, patients were allocated at random to receive treatment over a 4-week period. Buspirone dose ranged from 10 to 60 mg. Patients were assessed on entry and at weekly intervals using the 14 symptom groups (items) of the Hamilton Anxiety Rating Scale (HAM-A). Buspirone improved all symptom groups significantly; onset of anxiolytic activity was observed at week 1 in 3 groups of psychic symptoms of anxiety. Within 2 weeks, 8 of the 14 symptom groups were improved significantly by buspirone versus placebo, and symptoms of anxiety improved further up to the 4-week end point. Psychic symptoms of anxiety improved earlier in general than the somatic symptoms of anxiety. At the end of treatment, analyses of the HAM-A scores indicated that all of the 14 symptom groups (individual items), the total HAM-A score, and the 2 composite Psychic and Somatic Anxiety Factors were significantly improved with buspirone as compared to placebo. The beneficial effects of buspirone were not compromised by any significant side effects.

Adult↗
PubMed1989

Serotonin-1A anxiolytics: an overview.

The selective serotonin-1A receptor partial agonist anxiolytics represent a new class of pharmacologic agents that have demonstrated efficacy in the treatment of generalized anxiety disorder (GAD). These compounds offer a completely different pharmacologic approach to this disorder from previous medications. The selective 5-hydroxytryptamine-1A (5-HT1A) anxiolytics buspirone, gepirone, ipsapirone, and SM-3997 have several important new and unique features that will be reviewed in this paper. These features include no cross-tolerance with alcohol or benzodiazepines, no evidence of abuse or misuse potential, and no withdrawal symptoms or rebound anxiety on cessation of therapy. The 5-HT1A anxiolytics have no muscle relaxant, sedative, or anticonvulsant properties and do not impair psychomotor functioning. They do have a slower onset of effect than standard benzodiazepines-clinical response is usually noted in 1-3 weeks. The side effect profile is quite different from that of the benzodiazepines. It includes gastrointestinal symptoms such as nausea and diarrhea, headache, dizziness, and restlessness. Some patients with GAD who have received chronic (greater than 1 month) benzodiazepine therapy may not respond as well to these compounds initially as will patients with no prior benzodiazepine treatment, especially if the benzodiazepine has been discontinued only recently. These compounds, buspirone in particular, have been shown to have excellent maintenance and prophylactic properties and to be well tolerated with long-term therapy (greater than 3 months). Because of their unique mechanism of action and side effect profile, and no evidence of misuse or abuse potential or interference with mental acuity, these compounds represent a definite advance in the pharmacologic management of GAD.

Animals↗
PubMed1989

An overview of fluoxetine, a new serotonin-specific antidepressant.

Fluoxetine is a new, chemically unique antidepressant. In contrast with antidepressants already on the market, its only significant neurophysiologic effect is inhibition of serotonin reuptake. Double-blind comparisons show it is as effective in the treatment of major depression as tricyclic antidepressants. It is free of most of the troubling side effects of currently available antidepressants, including anticholinergic effects and weight gain. In fact, it is commonly associated with weight loss which is independent of nausea, the most commonly reported adverse effect. The recommended dose is 20 mg per day, given in the morning or early in the day. Fluoxetine deserves consideration for depressed patients for whom the clinician wishes to avoid anticholinergic effects, sedation, and weight gain. It may be especially effective in patients with pronounced obsessive-compulsive symptoms, weight gain with depression or from antidepressants, and in patients who have not responded to tricyclic therapy.

Depression↗
PubMed1989

A comparison of nefazodone, imipramine, and placebo in patients with moderate to severe depression.

In this sample of moderately to severely depressed outpatients, nefazodone therapy proved superior to placebo. Nefazodone therapy was also associated with fewer dropouts from adverse effects than was imipramine. In view of these efficacy findings as well as the promising side effect and safety profile of nefazodone, further research is warranted to evaluate its therapeutic potential in the treatment of depressive illness.

Adult↗