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 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

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

Two hundred thirty patients with generalized anxiety and Hamilton Rating Scale for Anxiety (HAM-A) scores greater than or equal to 18 were subdivided at random, according to a double-blind design, into one group treated with 5-10 mg of oral buspirone t.i.d. or one group treated with 10-20 mg of oral oxazepam t.i.d. for 6 weeks. No anxiolytic treatment was allowed 3 months prior to trial entry. Analysis of demographic variables revealed no significant imbalance between the two treatment groups. Twenty patients were excluded from efficacy analysis because of treatment withdrawal before the first efficacy evaluation on Day 7. Another 4 patients were excluded because they were taking concomitant psychotropic medication. The remaining 206 patients displayed a decrease in HAM-A scores (mean +/- SD) from 23.9 +/- 4.1 to 10.6 +/- 7.7 in the buspirone group and from 23.9 +/- 4.2 to 11.5 +/- 8.0 in the oxazepam group. The two treatment groups were also found to be virtually identical in an "intent to treat" analysis of all 230 patients as well as in other ratings (Hamilton Rating Scale for Depression, Raskin Depression Scale, Covi Anxiety Scale, Physicians Questionnaire, global ratings, and Hopkins Symptom Checklist [HSCL]-56). However, oxazepam was never superior to buspirone in any of the efficacy analyses. Of the 230 patients, 127 spontaneously reported adverse events, including drowsiness, dizziness, headache, nausea, and nervousness. Adverse events were relatively similar in the two groups. In conclusion, buspirone and oxazepam appear to be equally effective in the treatment of generalized anxiety encountered by general practitioners. This outcome, in addition to a previously documented absence of any dependency liability, makes buspirone a clinically important anxiolytic drug.
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PMID:A double-blind, controlled trial in primary care patients with generalized anxiety: a comparison between buspirone and oxazepam. 221 67

One hundred forty outpatients with major depression were admitted to an 8-week, placebo-controlled, double-blind study of buspirone. Entry criteria included a Hamilton Rating Scale for Depression (25-item [HAM-D]) score of greater than or equal to 18 and a Hamilton Rating Scale for Anxiety (HAM-A), score of greater than or equal to 18. A flexible dose schedule ranging from 5-90 mg/day was employed. The mean dose of buspirone was 41-54 mg/day from Week 2 to the end of the study. Sixty-four percent of buspirone patients and 50% of placebo patients were melancholic; 64% of buspirone patients and 74% of placebo patients discontinued treatment before the end of the study. Extender data analysis showed that buspirone patients had significant (p less than .05) HAM-D score reductions compared with the placebo group at Weeks 2, 3, 4, and 6. The HAM-D retardation factor trended toward significance over placebo at Weeks 3, 4, and 6. HAM-D change scores for the subgroup of melancholic patients taking buspirone were significantly (p less than .02) better than those of the placebo-treated melancholic subjects at Weeks 2, 3, 4, and 6. Most other efficacy parameters also favored the buspirone-treated group over the placebo-treated group. The most common adverse experiences for the buspirone group were CNS effects (74% in the buspirone group vs. 21% in the placebo group) and gastrointestinal effects (55% in the buspirone group vs. 37% in the placebo group). Side effects consisted of dizziness, light-headedness, nausea, and headache. No serious or unexpected adverse effects occurred.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Buspirone in the management of major depression: a placebo-controlled comparison. 221 70

A multicenter, double-blind, between-patient trial comparing two doses of ketazolam (15 and 30 mg) with placebo, each given once daily, in the evening, to 92 outpatients affected by generalized anxiety disorders for at least 1 month, was carried out. After 1-week washout period 47 patients were randomized to ketazolam 15 mg, and 45 to placebo for 15 days (first period). At the end of this period, if the patient experienced a decrease on the total Hamilton Anxiety Rating Scale (HAM-A) of at least 25% of basal value, the treatment was kept unchanged for a further 15 days, otherwise 15 mg of ketazolam were added to the previous treatment (second period). Anxiety was rated after 2 and 4 weeks with the Italian HAM-A scale and with a 4-point scale (patient's assessment). Seventy-eight patients completed the first period and 75 the whole study. During the first period the percentage of responders was almost identical in both treatment groups, but during the second period a further slight improvement was observed in the early placebo responders, while the HAM-A score of patients on ketazolam continued to improve significantly (p less than 0.01) throughout the study. Likewise a significant (p less than 0.001) difference between treatments was observed, on the 4-point scale, in the population as a whole (end of first period) as well as in responder patients (end second period). Tolerability was good, except in 1 patient on placebo, who was withdrawn from the study because of severe headache.
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PMID:Low doses of ketazolam in anxiety: a double-blind, placebo-controlled study. 290 33

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

Zimeldine, imipramine and placebo were studied in a randomized, double-blind, parallel group comparison of 119 patients with primary affective disorders. These out-patients were between 18 and 65 years of age and all received placebo single-blind during an initial 3-7-day washout period. During the subsequent 6-week double-blind period, patients were titrated from 50 mg b.d. to 150 mg b.d. with zimeldine, a potent and selective inhibitor of 5-HT reuptake, with imipramine, an inhibitor of noradrenaline and 5-HT reuptake, or with a corresponding number of placebo capsules. The zimeldine treatment group had significantly lower mean HAM-D scale total scores than the placebo and imipramine groups at week 4 and last available assessment. There was a significantly greater proportion of patients showing an improvement of 50% or more in HAM-D score, among the zimeldine group than in the placebo group at week 4, and among the imipramine group at weeks 4, 6 and last available assessment. The Clinical Global Impression (CGI) scales and the 56-item Hopkins Symptom Check-list (HSCL-56) self-rating inventory both showed significantly more improvement in the zimeldine patients than in the placebo or the imipramine patients. Fewer zimeldine patients reported adverse experiences than imipramine patients. Dry mouth was the most frequently reported adverse experience, occurring significantly more often in the imipramine group than the zimeldine or the placebo groups; significantly more zimeldine than placebo patients reported dry mouth. Headache was the only other adverse experience which occurred more often in the zimeldine than in the placebo group. The imipramine group had consistently higher mean pulse rates than the other two groups, and postural hypotension was also more common in the imipramine group.
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PMID:A double-blind, controlled evaluation of zimeldine, imipramine and placebo in patients with primary affective disorders. 623 Aug 97

In a 6-week double-blind study, 220 patients with major depression (mostly outpatients) were randomly assigned to receive a fixed dose of brofaromine 150 mg daily (n = 111) or placebo (n = 109) after a 1-week single-blind placebo washout. Except for the HAM-D sleep items, brofaromine was superior to placebo on measures of depression as determined by the four methods of assessing drug efficacy: (1) psychiatric symptom rating (HAM-D 17-item less the three sleep items); (2) self-rating scale (Beck Depression Inventory); (3) Clinical Global Assessment of Efficacy; and (4) drop-out rate due to lack of efficacy. Most commonly reported adverse events with brofaromine were: headache, nausea, dizziness and sleep disturbance. Brofaromine was found to be an effective antidepressant, superior to placebo with a good tolerability profile.
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PMID:A Canadian multicentre placebo-controlled study of a fixed dose of brofaromine, a reversible selective MAO-A inhibitor, in the treatment of major depression. 782 62

1. The present study evaluated the safety and efficacy of two dosages of SC 48,274 (1mg and 25mg) as compared to placebo in subjects with Generalized Anxiety Disorder (GAD). 2. This was a randomized, double-blind, placebo-controlled, parallel-group study which was part of one of three large multicenter trials which evaluated a total of 5 doses of SC 48,274 (.25, 1, 5, 25, and 100mg bid). Following a 7-day placebo baseline period, patients entered 4 weeks of double-blind treatment and a 7-day placebo follow-up period. 3. Efficacy was assessed weekly throughout the study with the Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression (CGI), and at treatment endpoint with the Covi Anxiety Scale, Raskin Depression Scale and Hamilton Depression Rating Scale (HAM-D). A diagnosis of GAD according to DSM-III-R criteria (with the exception that a GAD minimum duration of 3 months was allowed), a HAM-A score > or = 20 (anxious mood and tension items > or = 2), HAM-D less than HAM-A, Covi Anxiety Score > or = 8, Raskin Depression Scale less than the Covi Anxiety, and age of 18 to 65 years were necessary for inclusion in the study. 4. Patients received one of two dosages of SC 48,274, either 1mg (n = 28), 25mg (n = 9), or placebo (n = 28) bid, during the 4-week randomized portion of the trial. 5. Mean changes from baseline in HAM-A scores for the 1mg, 25mg, and placebo groups after 4 weeks treatment were -5.1, -4.2, and -1.9, respectively. Changes were significant for the 1mg group vs. placebo (F = 8.93, p = 0.004), but not for the 25mg group (F = 2.26, p = 0.138). 6. CGI severity of illness scores were also significant for the 1mg group versus placebo at the end of treatment (X2 = 3.8, p = 0.05), but not for the 25mg group (X2 = 0.90, p = 0.343). Neither group showed significant CGI improvement scores by end of treatment. 7. The most frequent adverse events associated with the study drug (n = 37) were headache (n = 7), nausea (n = 3), palpitations (n = 4) and chest pains (n = 2). There was, however, no apparent pattern of adverse events distinguishing SC 48,274 from placebo.
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PMID:An evaluation of the anxiolytic SC 48,274 in generalized anxiety disorder (GAD) 793 70

Safety aspects [adverse events, blood pressure and heart rate, weight, and laboratory tests (liver parameters, hemoglobin, leukocytes)] of long-term treatment in 1,120 patients are discussed. Adverse events during this long-term treatment were also compared with those of a subgroup of these patients who, before long-term treatment, were treated on a short-term basis (n = 706). Efficacy [Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression of Efficacy (CGI), and occurrence of relapses and recurrences] in a homogeneous sample of 485 patients is also discussed. The adverse events most frequently observed during long-term treatment were insomnia, headache, and dizziness. Insomnia and headache were also most often occurring in the compared sample of patients with short-term treatment, whereas dizziness during this treatment period ranked at the fifth position. Supine and standing mean blood pressure did not consistently change during long-term treatment, the most prominent increases in comparison with baseline were seen in the period > 1 year of treatment (6.3 mm Hg supine/7.2 mm Hg standing). Comparison of blood pressure values in the hypertensive range at baseline and during long-term treatment revealed no statistical difference (McNemar test p = 0.07829). Mean heart rate slightly decreased during long-term treatment (by a maximum of 6.3 beats/min supine, 8.2 beats/min standing). Mean weight did not change between baseline and treatment end point. There were 23 patients with a weight loss of 10 kg or more and 16 patients with a weight gain of 10 kg or more. For none of the laboratory parameters tested was there a statistical significance regarding shifts from normal to pathological values. HAM-D mean total scores in the above-mentioned subgroup of patients decreased from 25.05 points at baseline (n = 485) to 7.88 points after 1 year of treatment (n = 139). Seventy-five patients who had favorably responded to treatment (total responders n = 300) relapsed during the first 6 months of treatment. During the second half-year of treatment the recurrence rate was 14.8%, and during the third 6 months the recurrence rate was 12.2%. CGI in the same subsample of patients in whom HAMD was evaluated (n = 485) compared with those patients who did not drop out during the short-term period up to 44 days and entered long-term treatment (n = 401) showed that the percentage of the ratings "no change/worse" was higher in the sample that also included patients who withdrew from treatment during the short-term period.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Safety and efficacy during long-term treatment with moclobemide. 795 86

(1) We evaluated efficacy of several treatments for HTLV-I-associated myelopathy (HAM) on the basis of our study on 254 HAM patients and of literature review. Improvement of motor disability more than fair response was obtained as follows: 82% in prednisolone, 69% in interferon-alpha, 92% in fosfomycin, 82% in high-dose vitamin C, 72% in blood purification therapy, 70% in heparin, 59% in salazosulfapyridine, 56% in thyrotropin-releasing hormone, 55% in erythromycin, 50% in mizoribine. (2) In the absence of clear guideline, the efficacy of zidovudine in the AIDS dementia complex has been demonstrated. There are also efficacy of amytriptylinein controlling HIV headache, corticosteroid in mononeuritis multiple and inflammatory myositis, hydrocortisone in autonomic neuropathy and plasmapheresis in distal sensory neuropathy respectively. Otherwise, it is emphasized that ddI, ddC and d4T have peripheral neuropathy as major, dose related side effect.
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PMID:[Therapy for HAM/TSP and AIDS]. 799 4


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