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.
The treatment of anxiety is one of the leading problems in medicine today. Although traditional anxiolytic drugs have been effective in reducing the symptoms of anxiety, their efficacy has often been ...achieved at the expense of the patient's quality of life. The sedative side effects and impaired psychomotor functioning associated with the use of benzodiazepine anxiolytics not only impede the success of therapy, but jeopardize the patient's safety. This article addresses these salient issues and provides evidence suggesting that the antianxiety drug buspirone better achieves the goal of optimal anxiolytic therapy with minimal unwanted effects.
Tricyclic antidepressant (TCA) medications are among the most widely used pharmacologic treatments for depression. However, a substantial number of patients fail to respond to these agents. Few ...standardized trials of pharmacologic treatments for TCA nonresponders are available. Bupropion has an apparently different mechanism of action than TCAs and represents a possible treatment for the TCA nonresponder. Based on positive results from pilot studies, a standardized study evaluating bupropion in TCA nonresponders was conducted. Forty-one depressed outpatients who had failed to respond to adequate documented TCA treatment, defined by specific criteria of dosage, duration, and plasma concentrations, entered a 1-week single-blind placebo phase, followed by an open 8-week bupropion treatment phase utilizing doses of up to the maximum daily dose of 450 mg. Response was measured by change on the Hamilton Depression Rating Scale (HAM-D), Clinical Global Impressions-Severity (CGI-S) and Improvement (CGI-I) Scales, and the Hamilton Anxiety Rating Scale (HAM-A). Bupropion treatment resulted in an improvement in depression on all outcome measures. Forty-nine percent were considered "responders," in that they achieved > or = 50% improvement on the 28-item HAM-D. Fifty-four percent were classified as responders based on a CGI-I rating of much or very much improved. Statistically significant improvement in depressive symptoms, measured by mean scores for the HAM-D, CGI-S, and HAM-A, was achieved at the end of the study (as compared to baseline). Twelve patients (32%) had a HAM-D score of < or = 10 at termination.
Bupropion HCl, a new nontricyclic antidepressant, produced marked improvement in 49 hospitalized patients with primary depression at doses of 300-600 mg/day. Bupropion resulted in statistically ...significant differences from placebo as early as day 5, and by the end of the 4-week study 79% (N = 27) of the bupropion patients and 13% (N = 2) of the placebo patients showed much to very much improvement. Bupropion and placebo had similar side effect profiles. Tremor and sweating were reported more often with bupropion and headache, nausea, and tiredness with placebo.
The nosology of primary affective disorders is discussed with specific application of a six-stage model for clinical diagnosis utilizing an integrated nosological approach. The six phases of the ...clinical diagnostic model include: 1) Clinical description with delineation from other syndromes. 2) Physical and neurological factors. 3) Laboratory studies including psychological testing. 4) Family studies (pedigree studies). 5) Longitudinal--natural history studies. 6) Treatment outcome studies. Utilizing this six-stage model, the specific attributes of several major diagnostic systems for the affective disorders are compared and discussed. Specific operational diagnostic criteria described by Feighner et al., the Research Diagnostic Criteria by Spitzer et al., DSM-III, and ICD-9-CM are compared, and the merits of each are discussed. The nosological breakdown of the affective disorders with emphasis on the primary versus secondary axis and the unipolar versus bipolar axis is presented. In view of the ongoing development of more specific biological management of the affective disorders, it is imperative that systematic operational diagnostic criteria be utilized in current research to enhance homogeneity of research populations and to enhance communication between research centers.
In summary, on the basis of our inpatient and outpatient double-blind control trials and open-label experience with trazodone, we find it to be an effective broad-spectrum antidepressant generally ...well tolerated by most patients. When atropine side effects of the standard tricyclic antidepressants and bridged tricyclic antidepressants are undesirable and medically contraindicated, trazodone should be one of the drugs of choice in major depressive disorders.
Forty-two outpatients with major depressive disorder were treated with oral fezolamine in a 6-week, three-center open-label study. Therapy was initiated at 100 mg/day; thereafter dosage was increased ...based on the response of the patient. Maintenance dosage usually ranged between 100 and 450 mg/day. Clinically significant improvement relative to the patient's prestudy state was observed after 2 weeks in both patient and physician-rating scales. Fifty-five percent of patients improved their Hamilton Psychiatric Rating Scale for Depression (HAM-D) scores by more than 50%. The median dose associated with a clinically significant response was 245 mg/day. Five of the 6 patients who dropped out did so because of gastrointestinal adverse effects. The most common adverse effects were nausea (36%), headache (29%), constipation (26%), and dry mouth (24%).
1 A double‐blind trial with parallel treatment groups was conducted to compare the safety and efficacy of mianserin with amitriptyline. 2 This was a six week trial with weekly visits. Measurements at ...each visit included: 21 item Hamilton Depression (HAMD) Scale. Clinical Global Impression (CGI) Scale and Treatment Emergent Symptom Scale (TESS). 3 Mianserin and amitriptyline were comparable with respect to efficacy. 4 More adverse experiences were reported by amitriptyline patients. The predominant amitriptyline adverse experiences were of the anticholinergic type; the predominant mianserin adverse experience was drowsiness/fatigue. 5 The Efficacy Index (EI), a scale combining efficacy and adverse experiences, clearly demonstrated the superiority of mianserin over amitriptyline.
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