Comparative efficacy of estazolam, flurazepam, and placebo in outpatients with insomnia.

The efficacy and safety of estazolam, an investigational triazolobenzodiazepine, and flurazepam were compared in 65 insomniac outpatients. Patients completed sleep questionnaires each morning. Global evaluations demonstrated that both treatments were significantly superior to placebo. However, estazolam was preferred over flurazepam in a global rating that reflected how well rested and refreshed the subjects felt on arising. Improvement in complaints of difficulty in going to sleep showed only a trend toward significance favoring estazolam and flurazepam over placebo. Residual daytime drowsiness and fatigue accounted for approximately 70% of all side effects with both active treatments. Significantly more side effects occurred with flurazepam than with estazolam. Flurazepam-treated patients had a significantly more severe rating of adverse reactions than did placebo-treated patients.

Comparison of buspirone and diazepam in generalized anxiety disorder.

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.

Hypnotic efficacy of a modified triazolodiazepine, brotizolam.

Fifty-nine outpatients with insomnia were treated in a 3-week study to assess the safety and efficacy of a new triazolothienodiazepine with a short t1/2, brotizolam. Therapy was initiated with 0.25 mg at night, but by the end of the study all subjects who were receiving brotizolam were taking 0.50 mg. Results indicate brotizolam efficacy as measured by daily subject and weekly physician questionnaires in essentially all sleep parameters, including global subject and physician evaluation of treatment efficacy, sleep latency and sleep maintenance, and quality of sleep. Tolerance to the hypnotic action of brotizolam was not observed after 21 days of daily dosing.

A double-blind placebo-controlled study of fluvoxamine and imipramine in depression.

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.

A placebo-controlled, double-blind comparison of clobazam and diazepam in the treatment of anxiety.

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.

Case report of carbamazepine-induced reticulocytes.

The authors present the case of a woman with bipolar disorder who developed reticulocytosis after two trials of carbamazepine. They urge that blood indices be carefully monitored whenever carbamazepine is used.

The measurement of psychological states by use of factors derived from a combination of items from mood and symptom checklists.

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.

The goal-attainment scale: an instructional guide for the delivery of social reinforcement.

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.

Metiapine: a double-blind comparison with chlorpromazine in acute schizophrenic patients.

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.