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Biomedical subjects

L F Fabre

Publications and source records attributed to L F Fabre.

At least 37 records · Page 2Linked to original sources

Depressive symptoms and intellectual functioning in anxiety patients treated with clorazepate.

The combined data from two 1970s anxiety studies that used clorazepate and placebo as controls were reanalyzed statistically with a focus on intellectual functioning and depressive symptoms. For the 176 patients given either clorazepate or placebo, significant improvement was observed on the mean scores of the intellectual item and the depressive item of the Hamilton Rating Scale for Anxiety; the clorazepate group was significantly more improved than the placebo group. Similar results were observed in patients' self-ratings. The authors conclude that clorazepate is effective in treating depressive symptoms and improving intellectual functioning in patients with generalized anxiety disorder.

Anti-Anxiety Agents↗

A fixed-dose clinical trial of fluoxetine in outpatients with major depression.

Fixed daily doses of 20 mg, 40 mg, or 60 mg of fluoxetine, a highly specific serotonin reuptake inhibitor, were given to 84 depressed outpatients in a double-blind, placebo-controlled, randomized 6-week trial. The 20-mg dose produced improvement of depression in the moderate-severe depression group as expressed in significant reductions of scores on the Hamilton Rating Scale for Depression (p greater than or equal to .007) and the Patient Global Impressions scale (p greater than or equal to .011), and the 20-mg dose caused fewer side effects than did the higher doses. A mildly depressed group of patients showed no improvement at any dose level of fluoxetine.

Adolescent↗

Treatment of depression in outpatients: a controlled comparison of the onset of action of amoxapine and maprotiline.

In a 4-week double-blind study, amoxapine and maprotiline were compared in the treatment of 76 outpatients with moderate to severe depressive illness. Mean maximum daily dosages were 230 mg for amoxapine and 165 mg for maprotiline. The data suggest that in these dosages amoxapine and maprotiline are equally effective overall. However, significant differences favored amoxapine at Days 4 and 7, in agreement with other studies showing early onset of therapeutic action of amoxapine.

Adult↗

Comparison of alprazolam, imipramine, and placebo in the treatment of depression.

Alprazolam is the first of the triazolobenzodiazepines to be studied in a large population of depressed patients. In a six-week, double-blind multicenter comparison of alprazolam, imipramine hydrochloride, and placebo in the treatment of 723 patients with depression, the two active drugs were statistically more effective than placebo. Alprazolam was at least as effective as imipramine in relieving depressive symptoms, significantly more effective in relieving somatic symptoms, and showed an earlier onset of activity in some measurements. Anticholinergic side effects were reported most often by patients receiving imipramine, while drowsiness was the only side effect reported most often in the alprazolam group. The Feighner Diagnostic Criteria and prestudy and poststudy intercenter conferences with videotaped patient interviews ensured interrater reliability.

Adolescent↗

Long-term therapy for depression with trazodone.

Trazodone and imipramine were compared in a two-center double-blind study of moderately to severely depressed outpatients. Results for 44 patients who have completed the 12-month comparison showed superior efficacy of trazodone at endpoint on all efficacy measures. Significant differences were also seen on individual Hamilton Depression Rating Scale items, with lower anxiety scores at 5 evaluation points for the trazodone group. Clinical Global Impressions ratings also favored trazodone treatment. Anticholinergic effects and tremor were significantly more frequent in imipramine-treated patients, whereas drowsiness was more frequent with trazodone. No significant changes were seen in blood pressure or ophthalmologic exams; 2 trazodone patients and 1 imipramine patient developed slight ECG changes during therapy; these may have been age-related. Continued clinical benefit has been seen in 12 patients who have received open-label trazodone for additional periods of up to 3 years. These findings show trazodone to be clearly effective in long-term treatment of moderate to severe depression; the drug may be of particular benefit when atropine side effects pose serious problems, as in the elderly and patients with cardiovascular disorders.

Ambulatory Care↗

A multicenter evaluation of bupropion versus placebo in hospitalized depressed patients.

Bupropion, a new antidepressant with a novel structure and neurochemical profile, was compared to placebo in a three-center evaluation. Seventy-five depressed inpatients, 48 on bupropion and 27 on placebo, participated for up to 28 days. At dosages of 300-600 mg/day, bupropion was significantly more active than placebo in reducing depressive and anxious symptomology, beginning at the 3-week evaluation. Bupropion was particularly efficacious in more severely ill and older patients. Symptoms reflecting cognitive disturbance, somatic anxiety, and psychomotor retardation were most improved; sleep disturbances showed less marked effects. Appetite and diurnal variation were not markedly influenced. Adverse effects were minimal, with no significant cardiovascular or clinical laboratory findings. Three patients developed a skin rash. There was a notable absence of sedative, anticholinergic, and cardiovascular-related side effects. Bupropion has demonstrated antidepressant effects and a spectrum of activity that holds promise for a difficult subgroup: the older depressed patient with retardation and cognitive disturbance.

Adolescent↗

Comparison of the therapeutic effect, tolerance and safety of ketazolam and diazepam administered for six months to out-patients with chronic anxiety neurosis.

Recently, it has been argued that benzodiazepines may not be safe or efficacious beyond 3 months continuous dosage. This study was designed to provide data regarding efficacy, safety, possible tolerance development, and possible withdrawal effects of administering ketazolam and diazepam for a 6-month period. Chronic anxiety patients were screened for participation according to specific inclusion and exclusion criteria. Of 139 patients, forty-four terminated prematurely for non-drug related reasons and are not included in the analysis. Of the ninety-five patients remaining, sixty-three were on ketazolam, and thirty-two on diazepam. Efficacy parameters included the Hamilton Anxiety Rating Scale, Physician's Global Impressions, Target Symptoms, Self-Rating Symptom Scale, and Patient's Global Impressions. Patients were evaluated weekly for the first month except for Week 3, and then seen bi-weekly and rated monthly. The results of the study showed that ketazolam was as efficacious as diazepam in treating anxiety and resulted in fewer side-effects. No adverse effects were noted in either group. Both benzodiazepines were safe and well-tolerated. No tolerance or withdrawal effects were noted. The average doses were ketazolam Week 4 (50.0 mg), Week 24 (66.14 mg) and diazepam Week 4 (26.33 mg) and Week 24 (33.0 mg). An increase in anxiety occurred in a significant number of patients after termination of either drug. By 2 weeks after the last dose many patients were free of anxiety and did not require further treatment. These results demonstrate that benzodiazepines are safe and efficacious for at least 6 months of continuous dosage.

Adolescent↗

A double-blind comparison of prazepam with diazepam, chlorazepate dipotassium and placebo in anxious out-patients.

The study compared prazepam with diazepam, chlorazepate dipotassium, and placebo in the treatment of anxious out-patients. Patients were screened for participation in the study to be sure they met the criteria for inclusion. Patients were excluded if they had complicating physical or mental problems. All patients signed an informed consent. Seventy-three patients entered the study, thirteen did not complete at least two weeks of treatment and were not used in the data analysis. Of these thirteen, ten did not return and were lost to follow-up, tow entered the hospital for reasons unrelated to the drug study, and one patient on diazepam was terminated because of increased anxiety. Six patients were used in the data analysis, thirty-six males and twenty-four females with an age range of 21-61 years. Side-effects were minimal. Drowsiness was reported by two people in the placebo group, one taking chlorazepate dipotassium, three on prazepam and one on diazepam. One diazepam patient reported nausea and vomitting. Scores on the Zung Self-Rating Scale for Anxiety showed all three drug groups to be superior to placebo. The Hopkins Symptom Check-list found prazepam and diazepam to be superior to placebo and chlorazepate. No differences among the groups were found in the Hamilton Anxiety Scale. Prazepam may offer advantages over the other available benzodiazepines since it may be more readily absorbed than chlorazepate and has less side-effects than diazepam.

Adolescent↗

Multi-clinic double-blind comparison of triazolam (Halcion) and placebo administered for 14 consecutive nights in outpatients with insomnia.

In this multi-clinic double-blind study, patients suffering from insomnia were treated with triazolam 0.5 mg (Halcion) or placebo for 14 days. Four investigators treated 239 patients, 122 on triazolam and 117 on placebo. Thirty-nine patients, 10 on triazolam and 29 on placebo, dropped out for ineffectiveness of the medication and 32 patients, 16 in each group, dropped out for side effects. Analysis of pooled efficacy data showed that triazolam was significantly better than placebo on all efficacy parameters measured, including how much the medication helped the patients sleep, onset of sleep, duration of sleep, duration compared to usual, number of nocturnal awakenings, and feeling of restfulness in the morning. Triazolam did not produce evidence of tolerance development after 2 weeks of treatment. The same variety of side effects occurred on each treatment and primarily included drowsiness, grogginess, headaches, impaired coordination nausea, and dizziness.

Adolescent↗

Multiclinic double-blind comparison of triazolam and flurazepam for seven nights in outpatients with insomnia.

In this two-clinic seven-day double-blind study, 0.5 mg triazolam (Halcion) was compared to flurazepam (Dalmane) in the treatment of insomnia. Two clinical investigators completed 118 outpatients, 61 on triazolam and 57 on flurazepam. Five patients, four on triazolam and one on flurazepam, discontinued because of side effects; and three patients, one on triazolam and two on flurazepam, discontinued because of ineffectiveness of the medication. Analysis of pooled data for the 110 evaluable patients showed that 0.5 mg triazolam was significantly better than 30 mg flurazepam on the following parameters: (1) how much the medication helped the patients sleep, (2) onset of sleep, (3) duration of sleep, (4) evaluation of duration of sleep, and (5) feeling of restfulness in the morning. The trend for all other parameters favored triazolam treatment, but the values did not reach statistical significance. Side effects were similar in both groups, with drowsiness being reported most frequently. No change in efficacy indicating tolerance development during the seven days of drug administration was observed in either group.

Adolescent↗

Pilot open-label study of alprazolam (U-31,889) in anxious alcoholic out-patients.

Twenty out-patients suffering from anxiety and tension after withdrawal from alcohol were treated for 28 days with alprazolam. Three patients dropped out for intercurrent events, and 2 dropped out for recurrent drinking. Of the 15 patients completing the study, analysis of variance showed significant improvement in all Physician's Ratings as well as all patient self-ratings. At the 28th day, 93% of the patients rated moderate to marked improvement on the Physician's Global Impression and Therapeutic Effect, and 93% self rated at least a little better. Side-effects were generally mild and inconsequential. No adverse effects attributable to alprazolam were noted on laboratory evaluations, EKG's or ophthalmologic examinations.

Adult↗

Multi-clinic cross-over comparison of triazolam (Halcion) and placebo in the treatment of co-existing insomnia and anxiety in anxious out-patients.

In this multi-clinic double-blind cross-over designed study, forty-five anxious and insomniac out-patients received either triazolam (Halcion) 0.25 mg or placebo at bedtime. After seven days the medications were crossed over. The dosage was doubled after nights 2 and 9 if good sleep was not produced. Three patients dropped out, two on placebo (one for side effects and one for lack of efficacy) and one on triazolam (due to misunderstanding instructions). Analysis of sleep questionnaire data showed superiority of triazolam to placebo (p less .001) in all parameters. The incidence of dreams was not affected. Analysis of antianxiety efficacy showed that triazolam was superior to placebo (p less than .001) in all parameters, both physician's and self ratings. Thus, either triazolam or a good night's sleep significantly relieved the patient's anxiety. No side effects or abnormal laboratory values of significance were attributable to triazolam.

Adolescent↗

Double-blind placebo-controlled efficacy study of ketazolam (U-28,774).

The safety and efficacy of ketazolam (15 mg capsules) was compared to placebo in seventy-nine out-patients suffering from psychoneurotic anxiety, moderate or worse in severity. A flexible dosage range of 15-75 mg was used in this double-blind study lasting twenty-eight days. The average optimum therapeutic dose of ketazolam was 46-9 mg administered as a once-day dose at bedtime. Ketazolam was found to be significantly better than placebo in alleviating anxiety and its concomitant symptomatology as measured by the Hamilton Anxiety Rating Scale, three Physician's Global Impressions, two Patient's Global Impressions, and three Target Symptoms. Fifteen patients dropped from the placebo group before completion of the study, and two withdrew from the ketazolam group. The patients receiving ketazolam experienced a greater reduction in symptomatology throughout the study when compared to the placebo group. Side-effects experienced by the ketazolam patients were less than, or equal to, the placebo patients. No deleterious side-effects occurred. No differences between the two groups were found for vital signs, EKG's, laboratory tests, or physical examinations.

Adolescent↗

Preference studies of triazolam with standard hypnotics in out-patients with insomnia.

One hundred and four patients suffering from insomnia took part in four different two-night double-blind crossover trials of triazolam. In three separate studies, triazolam 0-5 mg was compared to placebo, flurazepam 30 mg and chloral hydrate 500 mg. Triazolam 0-5 mg was found to be preferred and to be superior to placebo, flurazepam and chloral hydrate in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to the other treatments on the following: How much did the medication help you sleep, onset of sleep, duration of sleep and number of awakenings. Additionally, triazolam was superior to chloral hydrate on the feeling in the morning parameter. In another comparison of triazolam 0-25 mg to flurazepan 15 mg, triazolam was not significantly better than flurazepam on any of the efficacy parameters except that the patients felt more alert the morning following triazolam that following flurazepam. On all efficacy endpoints, trends for all parameters favoured triazolam 0-25 mg over flurazepam 15 mg. Untoward side-effects in these four studies were minimal.

Adolescent↗