-
Psychotherapy and Psychosomatics 2007
Topics: Bupropion; Buspirone; Depressive Disorder, Major; Dopamine Uptake Inhibitors; Drug Therapy, Combination; Female; Humans; Middle Aged; Serotonin Receptor Agonists
PubMed: 17700052
DOI: 10.1159/000104708 -
The Journal of Clinical Psychiatry Sep 1990Buspirone, an azapirone derivative and a 5-HT1A partial agonist, is the first nonbenzodiazepine anxiolytic introduced into medicine for the treatment of generalized... (Review)
Review
Buspirone, an azapirone derivative and a 5-HT1A partial agonist, is the first nonbenzodiazepine anxiolytic introduced into medicine for the treatment of generalized anxiety disorder. A series of well-controlled clinical trials demonstrated that its anxiolytic properties were similar to those of various benzodiazepines and significantly better than placebo. More recently, antidepressant effects were also observed. Patients with clinical indications for which buspirone seems to be particularly appropriate are those with generalized anxiety disorder, those with chronic anxiety, the anxious elderly, and, perhaps, many patients of all ages who suffer from mixed symptoms of anxiety and depression. Studies conducted with patients suffering from panic disorder have so far been inconclusive, and thus buspirone is, for the present at least, not recommended for routine treatment of panic disorder. Buspirone seems to be most helpful in anxious patients who do not demand immediate gratification or the immediate relief they associate with the benzodiazepine response. Slower and more gradual onset of anxiety relief is balanced by the increased safety and lack of dependency-producing aspects of buspirone. Finally, whether or not buspirone may possess "curative" properties, in addition to "anxiety-suppressant" properties, that allow the patient to improve coping skills with time requires further exploration.
Topics: Anxiety Disorders; Buspirone; Depressive Disorder; Female; Humans; Premenstrual Syndrome
PubMed: 2211569
DOI: No ID Found -
Alimentary Pharmacology & Therapeutics Jun 2023Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT receptor agonist, may... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Patients with gastroparesis and related disorders have symptoms including early satiety, postprandial fullness and bloating. Buspirone, a 5-HT receptor agonist, may improve fundic accommodation.
AIM
To determine if buspirone treatment improves early satiety and postprandial fullness in patients with symptoms of gastroparesis.
METHODS
This 4-week multi-centre clinical trial randomised patients with symptoms of gastroparesis and moderate-to-severe symptoms of fullness (Gastroparesis Cardinal Symptom Index [GCSI] early satiety/postprandial fullness subscore [ES/PPF]) to buspirone (10 mg orally) or placebo three times per day. The primary outcome was a change in the ES/PPF from baseline to 4 weeks. The primary analysis was per protocol intention-to-treat ANCOVA of between-group baseline vs. 4-week differences (DoD) in ES/PPF adjusted for baseline ES/PPF. Results are reported using both nominal and Bonferroni (BF) p values.
RESULTS AND CONCLUSIONS
Ninety-six patients (47 buspirone, 49 placeboes; 92% female, 50% delayed gastric emptying, 39% diabetic) were enrolled. There was no between-groups difference in the 4-week ES/PPF primary outcome: -1.16 ± 1.25 (SD) on buspirone vs -1.03 ± 1.29 (SD) on placebo (mean DoD: -0.11 [95% CI: -0.68, 0.45]; p = 0.69). Buspirone performed better than placebo in patients with severe-to-very severe bloating at baseline compared to patients with none to moderate: (ES/PPF DoD = -0.65 vs. 1.58, p = 0.003; p = 0.07). Among individual GCSI symptoms, only bloating appeared to improve with buspirone vs. placebo.
CONCLUSIONS
Patients with moderate-to-severe early satiety/postprandial fullness and other symptoms of gastroparesis did not benefit from buspirone treatment to improve the ES/PPF primary outcome compared with placebo. There was a suggestion of the benefit of buspirone in patients with more severe bloating.
TRIAL REGISTRATION
ClinicalTrials.gov NCT0358714285.
Topics: Humans; Female; Male; Buspirone; Gastroparesis; Double-Blind Method; Gastric Emptying
PubMed: 37052334
DOI: 10.1111/apt.17479 -
Journal of Child and Adolescent... Feb 2018An increasing number of abandoned clinical trials have forestalled efforts to advance the evidence base for the treatment of mood and anxiety disorders in children and... (Review)
Review
OBJECTIVES
An increasing number of abandoned clinical trials have forestalled efforts to advance the evidence base for the treatment of mood and anxiety disorders in children and adolescents. With this in mind, we sought to present and validate a Bayesian approach for the reanalysis of summary data in abandoned clinical trials and to review and re-evaluate available pharmacokinetic, tolerability, and efficacy data from two large, randomized controlled trials of buspirone in pediatric patients with generalized anxiety disorder (GAD).
METHODS
Prospective, randomized, parallel-group controlled trials of buspirone in pediatric patients with GAD as well as associated pharmacokinetic studies were identified and data were extracted. In addition to descriptive statistics, marginal posterior densities for each variable of interest were determined and a Monte Carlo pseudosample was generated with random draws obtained from the Student's t-distribution to assess, with inferential statistics, differences in variables of interest.
RESULTS
Buspirone was evaluated in one flexibly dosed (N = 227) and one fixed-dose (N = 341) trial in children and adolescents aged 6-17 years with a primary diagnosis of GAD. With regard to improvement in the sum of the Columbia Schedule for Affective Disorders and Schizophrenia GAD items, buspirone did not separate from placebo in the fixed-dose trial at low (95% CI: -0.78 to 2.39, p = 0.32) or high dose (95% CI: -0.87 to 1.87, p = 0.47) nor did it separate from placebo in the flexibly dosed study (95% CI: -0.3 to 1.9, p = 0.15). Drop out as a result of a treatment-emergent adverse event was significantly greater in buspirone-treated patients compared to placebo (p = 0.011). Side effects were consistent with the known profile of buspirone with lightheadedness occurring more frequently in buspirone-treated patients (p < 0.001).
CONCLUSIONS
Buspirone is well tolerated in pediatric patients with GAD, although two randomized controlled trials were underpowered to detect small effect sizes (Cohen's d < 0.15). Finally, Bayesian approaches may facilitate re-examination of data from abandoned clinical trials.
Topics: Adolescent; Anti-Anxiety Agents; Anxiety Disorders; Bayes Theorem; Buspirone; Child; Humans; Patient Dropouts; Randomized Controlled Trials as Topic
PubMed: 28846022
DOI: 10.1089/cap.2017.0060 -
The Annals of Pharmacotherapy Dec 1998The results of buspirone efficacy have been inconsistent and contradictory. The rate of smoking abstinence has been reported to range from 36% to 88% and 16% to 89% in... (Review)
Review
The results of buspirone efficacy have been inconsistent and contradictory. The rate of smoking abstinence has been reported to range from 36% to 88% and 16% to 89% in buspirone and placebo treatment groups, respectively. Only one controlled study reported buspirone efficacy in reducing nicotine withdrawal symptoms, although it was based on a small sample population and only 4 weeks of follow-up. The most recent studies have been unable to demonstrate the efficacy of buspirone in smoking cessation or in the relief of withdrawal symptoms. A placebo-controlled, randomized trial with a large number of patients, relatively high doses of buspirone (30-60 mg/d), strict abstinence criteria, long-term follow-up, and the inclusion of smokers with general anxiety or anxiety reported in previous quit attempts is needed to further evaluate buspirone efficacy in smoking cessation and the reduction of nicotine withdrawal symptoms. The treatment effects of buspirone could then be specifically tested as a function of alleviating the anxiety component of the smoking withdrawal syndrome. Finally, buspirone may prove to be an alternative in patients unsuccessful with or unable to tolerate transdermal nicotine therapy. How buspirone compares with bupropion therapy for smoking cessation is also unknown.
Topics: Adult; Anti-Anxiety Agents; Buspirone; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Smoking Cessation
PubMed: 9876819
DOI: 10.1345/aph.17175 -
Alimentary Pharmacology & Therapeutics Jun 2023
Topics: Humans; Buspirone; Gastroparesis
PubMed: 37161626
DOI: 10.1111/apt.17511 -
The British Journal of Psychiatry.... Sep 1991Buspirone is an anxiolytic drug from the azapirone family of molecules. It differs chemically and pharmacologically from the benzodiazepines. Although its profile of... (Comparative Study)
Comparative Study Review
Buspirone is an anxiolytic drug from the azapirone family of molecules. It differs chemically and pharmacologically from the benzodiazepines. Although its profile of efficacy is comparable with that of benzodiazepines, it produces less drowsiness, less psychomotor impairment, less alcohol potentiation, and has less potential for addiction or abuse. Buspirone also appears to have efficacy in major depressive disorders, in comparison with placebo, but its activity in panic disorders is less impressive. It may diminish alcohol dependence both in animals and in chronic alcoholics. Clinical studies in the elderly show no important difference from younger patients in safety and efficacy profile, pharmacokinetics, and dosage requirement. The drug appears to be well tolerated in primary care settings and to be free of adverse clinical interactions with many drugs that might be used concomitantly. However, because its pharmacology differs from that of conventional anxiolytics, patients need to be informed about both its gradual onset of action and absence of euphoria and immediate sedation.
Topics: Anxiety Disorders; Buspirone; Depressive Disorder; Humans; Product Surveillance, Postmarketing
PubMed: 1840762
DOI: No ID Found -
Pharmacotherapy 1988Buspirone (Buspar) is a azaspirodecanedione anxiolytic agent. Its mechanism of action is extremely complex, but current investigations indicate that its main... (Review)
Review
Buspirone (Buspar) is a azaspirodecanedione anxiolytic agent. Its mechanism of action is extremely complex, but current investigations indicate that its main neuropharmacologic effects are mediated by the 5-HT1A receptors. Other neuroreceptor systems could be involved, as buspirone displays some affinity for DA2 autoreceptors and 5-HT2 receptors. It has been proposed that inhibition of synthesis and release of serotonin result through the combined interactions of neuroreceptors and secondary messenger systems. This action leads to inhibition of the firing rate of 5-HT-containing neurons in the dorsal raphe. From this novel profile, that differs from that of the benzodiazepines, buspirone lacks anticonvulsant and muscle-relaxant properties, and causes only minimal sedation. The drug is rapidly absorbed after oral administration, with a mean bioavailability of 3.9%. After a single oral dose, the mean elimination half-life is 2.1 hours. Buspirone is mainly bound to albumin and alpha 1-acid glycoprotein. It is metabolized to an active metabolite 1-(2-pyrimidinyl) piperazine (1-PP). The mean elimination half-life of 1-PP is 6.1 hours. Buspirone is indicated in the treatment of generalized anxiety disorders. Its efficacy is comparable to the benzodiazepines. Its use in depression and panic disorders requires further investigation. When combined with alcohol or given alone, psychomotor impairment was not detected. Abuse, dependence, and withdrawal symptoms have not been reported. The frequency of adverse effects is low, and the most common effects are headaches, dizziness, nervousness, and lightheadness. Buspirone should be added to drug formularies and could represent a significant addition in psychopharmacology.
Topics: Anxiety; Buspirone; Humans
PubMed: 3041384
DOI: 10.1002/j.1875-9114.1988.tb03543.x -
The Journal of Clinical Psychiatry Dec 1987A 12-month, multicenter, open-label study was conducted to evaluate the long-term safety and efficacy of the new nonbenzodiazepine anxiolytic buspirone. The study... (Clinical Trial)
Clinical Trial Review
A 12-month, multicenter, open-label study was conducted to evaluate the long-term safety and efficacy of the new nonbenzodiazepine anxiolytic buspirone. The study population consisted of 700 patients with DSM-III generalized anxiety disorder who ranged in age from 16 to 84 years. Ninety-two percent had symptoms of anxiety that had persisted for 3 months or longer. According to the Hamilton Rating Scale for Anxiety, the Physician Global Opinion of Improvement, and the Patient Opinion of Improvement, the use of buspirone resulted in a significant reduction in anxiety. The degree of this improvement correlated with the duration of drug use. After the third month of therapy, there was an extremely low incidence of patient discontinuation due to side effects or insufficient improvement. Adverse effects were typical of those observed in other double-blind, placebo-controlled studies that compared buspirone with benzodiazepines. Overall, buspirone was well tolerated for maintenance therapy.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anxiety Disorders; Buspirone; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Humans; Middle Aged; Time Factors
PubMed: 3320034
DOI: No ID Found -
The Annals of Pharmacotherapy Oct 1992
Review
Topics: Adult; Buspirone; Clinical Trials as Topic; Clomipramine; Drug Therapy, Combination; Female; Fluoxetine; Humans; Male; Obsessive-Compulsive Disorder
PubMed: 1421651
DOI: No ID Found