Brotizolam in the treatment of insomnia.
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Biomedical subjects
Publications and source records attributed to A F Jacobson.
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Outpatients with major affective disorder, unipolar depressed type (N=101), were treated in a 4-week placebo-controlled double-blind study to compare the efficacy and safety of fluvoxamine, a new serotonin reuptake inhibitor antidepressant, with imipramine and placebo. Therapy was initiated at 50 mg/day; thereafter, dosage ranged between 100 and 300 mg/day for both drugs. Results indicate statistically significant efficacy, measured by both patient and physician rating scales, for both active drugs over placebo. Fluvoxamine showed some evidence of earlier onset of action. Anticholinergic side effects were more common in the imipramine-treated patients, while fluvoxamine produced more gastrointestinal distress and insomnia.
In a randomized, placebo-controlled, double-blind study, the efficacy and safety of clobazam and diazepam were compared in 114 anxious outpatients. During the 4-week double-blind phase of the study, the mean daily dose was 59 mg for clobazam and 25 mg for diazepam. Results indicate statistically significant efficacy, measured by both patient and physician rating scales, for both active drugs compared to placebo. The incidence of sedation was similar for the two active treatment groups; dizziness was more frequent in the diazepam group.
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This investigation studied the effectiveness of in-hospital, individual counseling on the psychosocial adjustment of patients with newly diagnosed gynecologic malignancies. Levels of psychologic distress, sexual functioning, and return to employment were assessed at 3, 6, and 12 months after counseling. The counseled patients were compared with a similar control group that was assessed but not counseled. In this study, levels of psychologic distress reported by cancer patients were similar to those reported in normal populations. However, at 3 months post-treatment, counseled cancer patients reported significantly less confusion and contradiction within areas of self-perception than did the noncounseled patients. Return to employment and sexual activities were both shown to be adversely affected by the diagnosis and treatment of genital cancer. Results suggested that counseling had a positive effect in enhancing return to normal vocational and sexual functions during the 1st year after treatment.
The similarities in structure and usage of two widely used adjective checklists, the Profile of Mood States (POMS) and Symptom Checklist (SCL), suggested the feasibility of pooling the items from the two scales into a single factor analysis. This procedure was clinically appealing, statistically sound, and provided an efficient method to reduce and refine assessments of psychopathology. Data from 413 Miami Symptomatic Volunteers were used in this factor analysis. Nine factor dimensions were found to meet the dual criteria of statistical salience and clinical meaningfulness. The results demonstrated the factorial stability of the SCL and the POMS and identified the dimensions of psychopathology in which items from the two scales tended to complement each other in factor structure. Some factors were found to be unique to each scale. In addition, it was found that pooling the items from both scales yielded two new factor dimensions that were not previously available from either of the individual scales.
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Goal-attainment scaling, a method for evaluating treatment programs, has been reported to benefit therapeutic encounters. In order to evaluate its effect on staff therapeutic behavior, raters were trained to rate the appropriateness of inpatient behavior and the staffs' responses to it. General distribution of the goal-attainment scale on a psychiatric inpatient unit influenced the delivery of positive social reinforcement for appropriate behavior.
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Sixty newly admitted acute schizophrenic patients were randomly assigned to a double-blind trial of metiapine with a maximum dose of 450 mg per day versus a maximum dose of 450 mg per day versus a maximum daily dose of 900 mg chlorpromazine per day. At the conclusion of the study, 21 patients in each group showed marked to moderate improvement. There were significantly more marked improvers in the metiapine group then the chlorpromazine group on the Physician's Posttreatment Global Impression. Evaluation by analysis of covariance of the Brief Psychiatric Rating Scale showed a significant difference between treatment groups favoring chlorpromazine on the item of blunted affect. The spectrum of side effects was similar in the two groups, except for six patients treated with metiapine who displayed tachycardia on the EKG. This pulse elevation was reflected in the group data and is probably dose related. In conclusion, both drugs appeared to be equally efficacious in the treatment of newly admitted acute schizophrenic patients.
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A total of 66 outpatients meeting Diagnostic and Statistical Manual (DSM-III) criteria for generalized anxiety disorder began treatment in a randomized double-blind study that compared the efficacy and safety of buspirone and diazepam. Thirty-nine outpatients completed the 4-week trial. Both drugs were administered in a 1:1 dosage ratio; the daily prescribed dose did not exceed 40 mg. The mean daily dose of buspirone prescribed throughout the study was significantly higher than that of diazepam. Diazepam had a significantly earlier onset of efficacy than buspirone, although both drugs were equivalent after 4 weeks of treatment. Adverse reactions were more frequent in the diazepam group. Total scores from the Hamilton anxiety scale and physician's global ratings show that diazepam was significantly superior to buspirone during the initial 2 weeks of treatment. These findings are further corroborated by the results of patients' self-rated scales.
We prospectively studied 12 patients before and after bone marrow transplantation (BMT) with serial sonography to evaluate gallbladder sludge formation. Patients were studied on four separate occasions to assess the gallbladder for sludge and stones: prior to BMT and conditioning chemoradiation, and on days 3, 13, and 28 after BMT. During two of the sonographic studies, gallbladder volume measurements were made before and after administration of cholecystokinin octapeptide (CCK-OP) and the ejection fraction (EF) was calculated. Medical records were reviewed for symptoms of cholecystitis, narcotic use, and dietary intake. Sludge and/or stones developed in eight of 12 patients (67%), and in four patients sludge was observed by day 3 post-BMT. Ejection fraction was normal (> 50%) pre-BMT in six of the eight patients who developed sludge, and in four of these six post-BMT. Furthermore, five of the eight patients developed sludge and/or stones in the absence of fasting and/or narcotic use. We conclude that gallbladder sludge develops frequently and early in BMT patients and may resolve or progress to stone formation. We did not demonstrate a relationship between impaired contractility and the development of sludge and/or stones, nor did we find a strong association between sludge formation and conditions presumed to cause gallbladder stasis, such as narcotic use and fasting. These findings suggest that other factors apart from impaired gallbladder contractility may play a role in the formation of sludge in the BMT patient.