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Biomedical subjects

J B Cohn

Publications and source records attributed to J B Cohn.

At least 37 records · Page 2Linked to original sources

Double-blind, multicenter comparison of sertraline and amitriptyline in elderly depressed patients.

Two hundred forty-one elderly depressed patients entered the 8-week, double-blind phase of this parallel-group, multicenter study; 161 patients were randomized to receive sertraline (50-200 mg/day) and 80 were randomized to receive amitriptyline (50-150 mg/day). Among evaluable patients, there were no statistically significant differences between treatments in any of the primary efficacy variables: change in total Hamilton Rating Scale for Depression (HAM-D) score (17 items), percentage change in HAM-D score, change in HAM-D Item 1, change in Clinical Global Impressions (CGI) Severity score, change in the Depression Factor of the 56-item Hopkins Symptom Checklist, and the CGI Improvement score at the last visit. Similar results were obtained using data from all patients (intention-to-treat analysis), except that amitriptyline was superior in HAM-D Total score (p = .044). The two drugs produced a similar degree of response: on the basis of the HAM-D criterion, 69.4% of sertraline patients and 62.5% of amitriptyline patients responded, and, on the basis of CGI criterion, 79.5% of sertraline and 73.4% of amitriptyline patients responded. Twenty-eight percent of the sertraline patients withdrew from the study because of a treatment-related side effect and 2.5% (4) because of a laboratory abnormality. In comparison, 35% of the amitriptyline patients withdrew because of treatment-related side effects. Sertraline was associated with a statistically lower frequency of somnolence, dry mouth, constipation, ataxia, and pain and a higher frequency of nausea, anorexia, diarrhea/loose stools, and insomnia; thus, anticholinergic effects were less common and gastrointestinal effects were more common with sertraline than with amitriptyline.(ABSTRACT TRUNCATED AT 250 WORDS)

1-Naphthylamine↗

A comparison of fluoxetine imipramine and placebo in patients with bipolar depressive disorder.

This was a 6-week, double-blind comparison of fluoxetine, imipramine, and placebo in 89 patients with bipolar depression. Using the criteria of greater than or equal to 50% improvement in the HAMD-total score after at least 3 weeks on study drug, endpoint analysis showed 86% of the fluoxetine-treated patients improved compared with 57% of the imipramine-treated and 38% of the placebo-treated patients. Significantly fewer fluoxetine-treated patients discontinued due to adverse events than did imipramine-treated patients (7% vs. 30%, respectively).

Adolescent↗

Analysis of individual symptoms in generalized anxiety--a pooled, multistudy, double-blind evaluation of buspirone.

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.

Adult↗

Efficacy and safety of pentoxifylline in geriatric patients with intermittent claudication.

The effects of pentoxifylline on intermittent claudication were evaluated at a dose of 1200 mg/day in an open-label twelve-week study on geriatric patients with chronic occlusive arterial disease (COAD). Standardized treadmill testing and clinical signs and symptoms of COAD were followed up before and during drug administration. Twenty-four subjects with a mean age of 73.5 years, capable of walking between 20 and 200 meters on the treadmill, were entered into the trial; 22 participated for eight weeks and 19 completed the study in terms of treadmill walking distance measurements at 12 weeks. The mean walking distance for all patients was increased 111% over baseline at week 12. Thirteen subjects were considered drug responders (greater than or equal to 50% increase in treadmill walking distance) and 9 were considered nonresponders (less than 50% increase). Improvements in clinical signs and symptoms of COAD were noted. Decreases in elevated systemic systolic pressures (but not diastolic) were unexpectedly observed in many drug responders. Seven of 19 males reported sexual function improvements while receiving pentoxifylline. Fourteen (58%) of the 24 subjects reported mild side effects of dyspepsia, nausea, vomiting, dizziness, headache, or insomnia; no subjects were withdrawn from the study because of side effects. In summary, pentoxifylline improved function and symptoms in 13 of 22 geriatric patients with intermittent claudication; the drug was safe and well tolerated at the usual dosage in this geriatric patient population.

Aged↗

A pooled, double-blind comparison of the effects of buspirone, diazepam and placebo in women with chronic anxiety.

Pooled data were analyzed for 367 female patients enrolled in a double-blind, placebo-controlled, multi-centre trial comparing buspirone, a non-benzodiazepine anxiolytic, and diazepam in the treatment of generalized anxiety disorder. After a 4 to 7-day wash-out period, patients were allocated at random to receive one or other of the trial medications or placebo over a 4-week period. Mean daily dosages were 24.5 mg for buspirone and 20.8 mg for diazepam (range 10 mg to 60 mg for both drugs). Patients were assessed on entry and at weekly intervals using the Hamilton Anxiety Rating Scale, and at the end of treatment both patients and physicians gave an overall opinion of response to treatment. Details of adverse events were also recorded. The results showed that both buspirone and diazepam were approximately equal in efficacy and superior to placebo. Menstruation and the occurrence of premenstrual tension did not alter the anxiolytic activity of either drug. Patients taking diazepam had significantly more adverse effects, i.e. drowsiness, weakness, fatigue, inco-ordination and depression, than did those in the buspirone group. In a separate commentary, the anxiety disorder and the data from the study are reviewed to place them in the overall perspective of gynaecological care.

Adolescent↗

Adinazolam mesylate and placebo in depressed outpatients: a 6-week, double-blind comparison.

In 72 outpatients with DSM-III major depressive episode, adinazolam was superior to placebo in all measurements. Significantly more adinazolam-treated subjects (N = 36) than placebo subjects (N = 36) completed the study (67% vs. 19%), were rated "much" or "very much" improved (78% vs. 19%), and had a "moderate" or "marked" therapeutic effect of the drug (67% vs. 19%). The total Hamilton Rating Scale for Depression score decreased by 50% or more in 61% of the adinazolam group and in 17% of the placebo group; 72% of the adinazolam group reported that they felt "moderately," "much," or "very much" improved compared with 17% of the placebo group. The adinazolam group reported significantly more drowsiness and lightheadedness, dizziness, or faintness; the severity of these side effects decreased with time. No significant anticholinergic effects were observed.

Adult↗

Double-blind comparison of buspirone and clorazepate in anxious outpatients.

Buspirone, a new nonbenzodiazepine anxiolytic agent, was compared with clorazepate in a double-blind, multicenter trial conducted with 336 outpatients who had moderate to severe anxiety. The two treatments were equally effective for relief of symptoms, including anxiety with associated depression. Although both agents were generally well tolerated, the profile of side effects was dissimilar. Drowsiness and depression occurred significantly (p less than 0.055) more frequently with clorazepate, whereas nausea and headache occurred significantly (p less than 0.055) more frequently with buspirone. Clorazepate-treated patients were significantly (p less than 0.055) more likely to have had an adverse experience that was considered drug related or that interfered with the therapeutic effect. In this study, buspirone was shown to be an effective antianxiety agent, causing significantly less sedation than clorazepate.

Administration, Oral↗

Neuroendocrine effects of buspirone in patients with generalized anxiety disorder.

This study investigated a therapeutic regimen of buspirone, a new anxioselective drug, in patients with generalized anxiety disorder. The single-blind study, conducted in 23 outpatients, consisted of 28 days of buspirone treatment followed by four days of placebo treatment. Patients received a single 10-mg dose of buspirone on study day one, which was titrated to 10 mg three times daily by study day seven and which remained at 10 mg three times daily through study day 28. Blood samples were drawn on days one, 14, 28, and 32 for determination of plasma levels of prolactin, growth hormone, and cortisol. The therapeutic effect of buspirone was assessed by standard psychometric rating scales. When titrated to a total daily dose of 30 mg per day (10 mg three times daily), buspirone provided effective antianxiety therapy and had no significant effect on plasma levels of prolactin, growth hormone, or cortisol.

Administration, Oral↗

Low-sedation potential of buspirone compared with alprazolam and lorazepam in the treatment of anxious patients: a double-blind study.

Buspirone was compared to alprazolam and lorazepam in the treatment of generalized anxiety disorder in a 4-week, double-blind study of 60 patients. All three medications were effective and similar in producing significant reductions in anxiety as assessed by standardized anxiety rating scales and by global evaluations of patients by physicians. There were significant differences in drowsiness, lethargy, and/or fatigue: fewer patients in the buspirone group than in the alprazolam group (16% vs. 60%, respectively; p less than .01) or the lorazepam group (16% vs. 65%, respectively; p less than .0003) experienced these undesirable side effects. This demonstration of similar effectiveness and superior safety would favor buspirone in the treatment of generalized anxiety disorder.

Adolescent↗

Effect of bromocriptine mesylate on induced hyperprolactinemia in stabilized psychiatric outpatients undergoing neuroleptic treatment.

Therapeutic doses of phenothiazines increased serum levels of prolactin, resulting in a number of side effects. Bromocriptine, a potent dopamine agonist, appears to effectively reduce the serum prolactin level. In this open pilot study, bromocriptine mesylate (Parlodel, Sandoz) was administered in an escalating dose schedule to 11 stabilized psychiatric outpatients with hyperprolactinemia resulting from thioridazine HCl (Mellaril, Sandoz) treatment. 6 of 9 patients showed decreases. Overall global psychiatric evaluations were unchanged over the course of combined therapy for all but 1 patient, who showed improvement. The trend of decreased prolactin serum levels indicates that bromocriptine mesylate may prove a useful adjunct to reduce the side effects of hyperprolactinemia.

Adolescent↗

Double-blind comparative trials of fluoxetine and doxepin in geriatric patients with major depressive disorder.

Fluoxetine was compared to doxepin in geriatric out-patients with major depressive illness. At the end of the 6-week double-blind study, the mean endpoint scores for all rating scales were significantly improved over base-line in both treatment groups. A subsequent 48-week open-label study supported the finding that both drugs are efficacious for maintenance therapy in elderly depressed patients. Fluoxetine, which lacks anticholinergic effects and is nonsedating, was well-tolerated by most patients and had fewer total side effects than doxepin. Common drug-related side effects for fluoxetine included nervousness/anxiety and nausea. Common side effects of doxepin were dry mouth, drowsiness/sedation, constipation, and dizziness/lightheadedness.

Age Factors↗

A comparison of fluoxetine, imipramine, and placebo in patients with major depressive disorder.

The efficacy and safety of fluoxetine were compared with those of imipramine and of placebo in a 6-week randomized double-blind parallel study of patients with major depressive illness. Mean values for all efficacy measurements were improved over baseline with fluoxetine and imipramine treatment (p less than .001). More fluoxetine patients completed the study than did imipramine or placebo patients. Predominant adverse experiences reported by imipramine patients were dry mouth and dizziness/lightheadedness. Predominant adverse experiences reported by fluoxetine patients were drowsiness/sedation and excessive sweating. In a subsequent 48-week open-label study, the predominant adverse experience in the fluoxetine group was excessive sweating and in the imipramine group was still dry mouth. In this study, fluoxetine relieved the symptoms of major depressive illness effectively and significantly better than placebo and was better tolerated than imipramine.

Adult↗

Double-blind crossover comparison of triazolam and lorazepam in the posthypnotic state.

A double-blind crossover study compared the hypnotic effect, daytime carryover, and safety of triazolam 0.5 mg, lorazepam 2 mg, and placebo. The two active drugs were similar in hypnotic effect and superior to placebo. Patients reported more drowsiness upon awakening and more sleepiness in mid-morning and mid-afternoon after nights on lorazepam than nights on triazolam or placebo. The most common side effects--drowsiness, lightheadedness, restlessness, impaired coordination, dizziness, and nausea--were reported three times as often with lorazepam than with triazolam or placebo.

Adolescent↗

A two-center double-blind study of nomifensine, imipramine, and placebo in depressed geriatric outpatients.

Both nomifensine and imipramine were superior to placebo in a 4-week double-blind study involving 63 geriatric patients (greater than 60 years) with primary affective disorder-depression. Significant improvement in the active drug groups was demonstrated on the Hamilton Depression Rating Scale, Clinical Global Impressions, Brief Psychiatric Rating Scale, and Hopkins Symptom Check List. Analysis of laboratory and physical examination data, including ECGs, revealed no clinically significant changes associated with either drug. Compared to the imipramine group, nomifensine-treated patients showed a more rapid rate of improvement and a lower incidence of discomforting side effects.

Aged↗

Triazolam treatment of insomnia in depressed patients taking tricyclics.

A double-blind crossover study in 53 psychiatric outpatients compared the safety and efficacy of triazolam and placebo in relieving insomnia refractory to treatment with a tricyclic antidepressant. Patients with a depressive disorder who had been taking a TCA for at least 6 weeks received triazolam or placebo for 4 days, neither medication for 1 day, and the alternative treatment for 4 days. The antidepressant regimen was maintained throughout the study. Sleep measurements showed triazolam to be consistently more effective than placebo in promoting and maintaining sleep and enabling the patient to awaken feeling rested. No worsening in depression or anxiety was seen with either triazolam or placebo; some measures indicated improvement in anxiety and depression symptoms on triazolam. One patient on triazolam dropped out because of side effects. The most common side effect was mild to moderate drowsiness.

Adult↗

Comparison of the effects of bupropion and amitriptyline on cardiac conduction in depressed patients.

Tricyclic antidepressants may prolong cardiac conduction as a result of their direct cellular membrane depressant effects. These effects can be evaluated by careful quantitative assessment of the electrocardiogram (ECG). This study compared the ECG effects of bupropion and amitriptyline at therapeutically comparable doses. No significant changes were seen with bupropion in any of the ECG parameters measured (PR interval, QRS duration, QTc interval, and QRS height). Amitriptyline, however, caused a significant prolongation in PR interval (p less than .01) and QRS duration (p less than .05), as well as a decrease in QRS height (p less than .001). These results suggest that bupropion is less likely to cause cardiac conduction abnormalities in patients prone to such problems, or in those patients who overdose.

Amitriptyline↗