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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The use of benzodiazepines for generalized anxiety disorder (GAD) is a safe and effective treatment; however, their potential to produce dependence and impair psychomotor and cognitive functions is a drawback. In this study the efficacy and safety of alpidem, a nonbenzodiazepine, was assessed. Thirty patients who met DSM-III-R criteria for GAD were randomized to either alpidem (225 mg), lorazepam (4.5 mg), or placebo. The primary efficacy measure was the Hamilton Rating Scale for Anxiety (HAM-A). A repeated measures multivariate analysis of variance (MANOVA) was used to determine differences in HAM-A scores over time. The results showed a trend for alpidem to be more effective. Half of the alpidem group had a decrease of 50 percent or greater in their HAM-A scores with an almost equal effect on psychic and somatic symptoms. The most common side effects with alpidem and lorazepam were lightheadedness, drowsiness, and daytime tiredness. Moreover, treatment with alpidem did not manifest any withdrawal symptoms. Thus nonbenzodiazepine treatments are effective and safe for GAD.
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PMID:A comparative study of alpidem, a nonbenzodiazepine, and lorazepam in patients with nonpsychotic anxiety. 167 74

Fluoxetine, a selective inhibitor of 5-HT uptake, was compared to dothiepin in a double-blind study of 6 weeks duration in 100 depressed patients (male and female) drawn from 8 general practices. Only those who scored at least 17 on the first 17 questions of the Hamilton Psychiatric Rating Scale for Depression (HAM-D) were selected. Both groups improved throughout the trial, though the dothiepin treated patients tended to improve quicker. However, by the end of the trial there was no statistically significant difference between the 2 groups. Subset analyses of HAM-D scores associated with anxiety and sleep revealed no statistically significant differences between the 2 treatments though improvement in anxiety scores was marginally greater for those receiving fluoxetine by the end of the trial. Other global assessments by patients and doctors confirmed the changes in HAM-D scores. Statistically significant weight changes occurred between visits 1 and 5. Whereas fluoxetine-treated patients lost weight (p less than 0.05), dothiepin-treated patients gained weight (p = 0.05) over this period. Adverse effects were reported in 27 patients given fluoxetine and 20 dothiepin. Of these, 14 fluoxetine and 7 dothiepin-treated patients withdrew before the end of the trial. The most common adverse effects were nausea, vomiting and diarrhoea in the fluoxetine group and tiredness, drowsiness and diarrhoea in the dothiepin group. There were no haematological or clinical chemistry changes.
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PMID:A double-blind comparative study of fluoxetine and dothiepin in the treatment of depression in general practice. 267 26

Sixty (60) out-patients with DSM III generalized anxiety disorder were treated after a 1-week placebo washout in a 4-week double-blind study with buspirone, diazepam and placebo; after which they were withdrawn abruptly from medication or assigned to a 2-week period of placebo. The HAM-A score was significantly lower in the diazepam group at week 2 (p less than .02) and the buspirone group at week 3 (p less than .04) as compared to the placebo group. A similar pattern was evident in the female group, but not in the male group. Dizziness was the most prominent adverse effect in the buspirone group, whereas the diazepam group had more adverse effects including sedation, fatigue, dizziness and impaired concentration. Withdrawal symptoms were more evident in the diazepam group than the buspirone group.
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PMID:Buspirone: anxiolytic? 286 95

The efficacy and safety of propranolol in the treatment of anxiety was compared with those of chlordiazepoxide and placebo in a 3-week, double-blind study of 212 patients. After a 1-week, single-blind placebo-washout period, patients were randomized to receive either propranolol (80, 160, or 320 mg/day), chlordiazepoxide (30, 45, or 75 mg/day), or placebo. Patients were evaluated by three physician-rated scales--Hamilton Rating Scale for Anxiety (HAM-A), Covi Anxiety Scale (CAS), and Clinical Global Impressions scale--and two patient-rated scales--Symptoms Checklist 90 and Profile of Mood States. Patients in all groups demonstrated significant improvement in their level of anxiety at all time points compared with their baseline level. At Week 1 propranolol and chlordiazepoxide patients were significantly better than placebo patients, as measured by the HAM-A and CAS. At Week 2 only propranolol was superior to placebo, based on HAM-A and CAS scores. Fifteen patients prematurely terminated because of adverse reactions (4 taking propranolol, 4 taking placebo, and 7 taking chlordiazepoxide). The incidence of side effects was similar for the two active drugs; fatigue, drowsiness, and change in libido were significantly more frequent with chlordiazepoxide and drowsiness and indigestion were more frequent with propranolol compared with placebo.
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PMID:Comparative efficacy of propranolol, chlordiazepoxide, and placebo in the treatment of anxiety: a double-blind trial. 330 88

The purpose of the present 6-week multicenter dose finding study was to compare the efficacy and tolerability of mirtazapine (preferentially presynaptic alpha 2-adrenergic receptor blocker) to placebo in hospitalized patients with major depression. The clinical efficacy was evaluated with the Hamilton Depression Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Self-Rating Depression Scale, Global Assessment Scale (GAS), and Brief Psychiatric Rating Scale (BPRS). The side effects were recorded on a checklist of emergent symptoms (ROSE) and physical examinations, ECG, clinical chemistry, and hematology tests were carried out. The dosages of mirtazapine were gradually raised from 15 mg to 50 mg. One hundred and fourteen patients were included. Twenty-two patients (37%) in mirtazapine group and 24 (44%) in the placebo group were prematurely withdrawn from the study mainly due to inadequate efficacy. The decrease in HAM-D and MADRS was generally more pronounced in the mirtazapine group than in the placebo group. Minor side effects were reported in less than 15% of the patients in both groups. Only fatigue and faintness were slightly more pronounced in the mirtazapine group than in the placebo group. No significant changes were found in laboratory parameters. Because of methodological flaws like combining a dose finding study with a placebo controlled study, further conclusions should not be made on the efficacy of mirtazapine when treating depressive patients.
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PMID:Double-blind study of mirtazapine and placebo in hospitalized patients with major depression. 791 44

Treatment with St John's wort extract tablets (hypericum Ze 117) and the commonly used slow serotonin reuptake inhibitor (SSRI) fluoxetine was compared in patients with mild-moderate depression with entry Hamilton Depression Scale (HAM-D) (21-item) in the range 16-24, in a randomized, double-blind, parallel group comparison in 240 subjects; fluoxetine: 114 (48%), hypericum: 126 (52%). After 6 weeks' treatment, mean HAM-D at endpoint decreased to 11.54 on hypericum and to 12.20 on fluoxetine (P < 0.09), while mean Clinical Global Impression (CGI) item I (severity) was significantly (P < 0.03) superior on hypericum, as was the responder rate (P = 0.005). Hypericum safety was substantially superior to fluoxetine, with the incidence of adverse events being 23% on fluoxetine and 8% on hypericum. The commonest events on fluoxetine were agitation (8%), GI disturbances (6%), retching (4%), dizziness (4%), tiredness, anxiety/nervousness and erectile dysfunction (3% each), while on hypericum only GI disturbances (5%) had an incidence greater than 2%. We concluded that hypericum and fluoxetine are equipotent with respect to all main parameters used to investigate antidepressants in this population. Although hypericum may be superior in improving the responder rate, the main difference between the two treatments is safety. Hypericum was superior to fluoxetine in overall incidence of side-effects, number of patients with side-effects and the type of side-effect reported.
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PMID:Equivalence of St John's wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression. 1075 36

More than two thirds of patients with depression present with symptoms of fatigue, low energy, and listlessness. Because daytime sedation may be a concern in such patients, a "nonsedating" antidepressant should be considered. The authors examined the effects of fluoxetine on depression-related disturbances in energy. Data from seven double-blind, placebo-controlled clinical trials in 2,075 patients with major depression were retrospectively analyzed. The Hamilton Rating Scale for Depression (HAM-D) Retardation factor score (total of items 1, 7, 8, and 14) was used as the primary measure of energy improvement, whereas the HAM-D-17 total score was used to assess changes in overall depression. Elderly patients (aged 60 years and older) were included in the overall group and were also analyzed separately. In addition, a subgroup analysis was performed using the HAM-D Retardation factor score to categorize patients as having low (score < 8) or high (score > or = 8) levels of retardation at baseline. Beginning at week 3, fluoxetine-treated patients experienced statistically significant reductions in their HAM-D Retardation factor score compared with placebo-treated patients. The reductions for the elderly subgroup were less than those for the overall population, but they were still statistically significant beginning at week 4. Patients in both the low and high baseline retardation groups improved significantly. HAM-D-17 total scores for fluoxetine-treated patients in all groups (total, elderly, high retardation, and low retardation) improved significantly compared with placebo-treated patients. These findings demonstrate that fluoxetine-treated patients experience an improvement in energy symptoms as their overall depression improves.
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PMID:Changes in energy during treatment of depression: an analysis of fluoxetine in double-blind, placebo-controlled trials. 1110 39

Somatization disorder (SD) is commonly seen in medical clinics and is associated with significant impairment in functioning as well as excessive utilization of health care. While antidepressants have been studied in some functional somatic syndromes such as fibromyalgia and chronic fatigue, there are no pharmacologic treatment studies of SD itself. In this prospective, 8-week, open-label study, 15 patients diagnosed with either full SD or abridged somatization, by Escobar's criteria (four unexplained physical symptoms for men or six for women), were given nefazodone, titrated to 150 mg bid. The primary outcomes included measures of physical symptom severity (visual analogue scale), functioning (SF-36), and overall improvement (CGI). Fourteen of the 15 patients achieved the target dose of 300 mg/day and completed the trial. 73% of the patients were rated as improved on the CGI, 79% improved on the self-rated visual analogue scale and 73% of the patients improved on the SF-36. There was significant improvement for the whole group (prepost) on the SF-36, as well as on the HAM-D and the HAM-A. Of the nine patients with a categorical depression diagnosis, 55% of them were rated as improved on the CGI, and 67% improved on both the VAS and the SF-36. Of the six nondepressed patients, 67% were rated as improved on the CGI, 83% improved on the SF-36, and 50% improved on the VAS. Adverse events were generally mild and resulted in only one discontinuation. Although these data need to be confirmed in a larger, double-blind, placebo-controlled trial, they suggest that patients with SD will accept and tolerate therapy with nefazodone and that nefazodone may be a useful treatment for these patients.
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PMID:Treatment of somatization disorder with nefazodone: a prospective, open-label study. 1179 53

The paper presents results of the study on the efficacy and tolerability of mirtazapine treatment of patients with depression. The study was open and conducted in three centers. 65 out- and in-patients with diagnosis of depression was included. 50% reduction of the score in the HAM-D scale was obtained in 57%, according to MADRS scale--in 61% patients. Side effects were reported in 49% patients. The most frequent side effects were: drowsiness, fatigue, anxiety, sleepiness, weight increase, headache. The results of the study are comparable with other mirtazapine studies.
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PMID:[Assessment of efficacy and tolerability of mirtazapine treatment of patients with depression]. 1264 30

Primary care patients with a major depressive disorder and 17-item Hamilton Rating Scale for Depression (17-HAM-D) score >18 were randomized to 24 weeks of treatment with mirtazapine 30-45 mg/day (n=99) or paroxetine 20-30 mg/day (n=98). Both treatments were efficacious in improving depressive symptomatology, as assessed by group mean 17-HAM-D scores, percentages of HAM-D responders and remitters and Clinical Global Improvement responders. The mirtazapine group showed statistically significantly larger decreases from baseline in group mean 17-HAM-D scores at weeks 1, 2 and 4, and the difference with the paroxetine group reached the level of clinical relevance at weeks 2 and 4. Antidepressant efficacy was maintained throughout both the acute and continuation phase of treatment. Both treatments were well tolerated. The only adverse event with a statistically significantly higher incidence in the mirtazapine group was fatigue. Statistically significantly more paroxetine-treated patients complained of increased sweating, headache and nausea. The results demonstrate that both mirtazapine and paroxetine were efficacious and well tolerated when used for 24 weeks in depressed patients treated in primary care. An observed difference in efficacy favouring mirtazapine between weeks 1 and 4 indicates that mirtazapine patients had improved earlier compared to those on paroxetine, and corroborates similar findings in other comparisons of mirtazapine versus selective serotonin reuptake inhibitors.
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PMID:A randomized, double-blind, 24-week study comparing the efficacy and tolerability of mirtazapine and paroxetine in depressed patients in primary care. 1270 91


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