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There was no difference in the ADOS Composite Total Score between baseline and 24 weeks among the 3 treatment groups (P = .400); however, the ADOS Restricted and Repetitive Behavior score showed a time-by-treatment effect (P = .006); the 2.5-mg buspirone group showed significant improvement (P = .003), whereas placebo and 5.0-mg buspirone groups showed no change. Children in the 2.5-mg buspirone group were more likely to improve if they had fewer foci of increased brain tryptophan metabolism on positron emission tomography (P = .018) or if they showed normal levels of blood serotonin (P = .044). Adverse events did not differ significantly among treatment groups.
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Buspirone hydrochloride, a compound with novel chemical structure, has been reported to be anxiolytic in man. Its mechanism of action as an anxiolytic is unknown, but preclinical studies have shown that it produces effects consistent with both a dopamine agonist and antagonist. In man, buspirone hydrochloride at doses of 30, 60, and 90 mg orally significantly elevated plasma prolactin (PRL) and growth hormone (GH) concentrations. The apparent increase in PRL secretion was dose dependent, but that of GH was not. The increase in PRL secretion could be due to a dopamine antagonist effect at the pituitary gland. A dopamine agonist action at hypothalamic dopamine receptors could account for the increase in GH secretion. Benzodiazepine anxiolytic drugs also increase serum GH levels in man, by a mechanism that has not been clearly established. It may be that buspirone and benzodiazepine drugs stimulate GH secretion by a common mechanism that is related to their anxiolytic actions.
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Most laboratory research on aggressive behavior has focused on intraspecific intermale aggression tests. The intraspecific confrontation is not available for the evaluation of female aggressiveness, since androgens are critical for maintenance of this behavior, whereas aggressive biting behavior toward inanimate objects (ABI) occurs in both males and females.
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Rats were habituated to ad lib food intake from two isoenergetic diets that differed in carbohydrate and protein content. To examine the route of administration effect, buspirone (0.6, 1.0, and 1.4 mg/kg) was injected into satiated rats either subcutaneously or intraperitoneally. Overall, no route of administration effect was observed; however, when results of the lowest dose were analyzed separately, the subcutaneous route was more effective than the intraperitoneal route. Regardless of route of administration, buspirone increased food intake over the first 2 h of food presentation in a dose-dependent manner. Moreover, the increase was entirely attributed to increases in intake from the high carbohydrate diet. In the subsequent experiment, the effect of buspirone (0.6 mg/kg) was examined in both satiated (early light period) and nonsatiated rats (early dark period). Both groups responded to buspirone with an increase in carbohydrate intake. Despite differences in baseline intake, the absolute increase was similar between satiated and nonsatiated rats. These data suggest that both sensitivity and selectively of buspirone-induced feeding are neither influenced by route of administration nor nutritional status of rats.
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Elderly patients have a higher prevalence of clinically significant anxiety than younger patients. The anxiety is usually comorbid with depression, medical illness, dementia, or personality disorders, and all of these factors impact on treatment. Further complicating treatment are age-related changes in the pharmacokinetics and pharmacodynamics of anxiolytics in this patient population. Benzodiazepines, buspirone, beta-blockers, antidepressants, neuroleptics, and antihistamines are useful in treating anxiety in older patients, but individual patient physiologic and psychological characteristics need to be considered in choosing an appropriate agent.
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Poisoning by organophosphate nerve agents can induce seizures which rapidly become refractory to treatment and result in brain damage. Current therapies have only a narrow time frame for effective administration after poisoning. 5-HT1A agonists were tested for efficacy in mice against a seizure-producing combination of the carboxylesterase inhibitor 2-(o-cresyl)-4H-1:3:2-benzodioxaphosphorin-2-oxide (CBDP) and sarin, producing an LD20-40. Administration of the 5-HT1A agonist, 8-hydroxy-2-(di-n-propylamino)tetralin (8-OH-DPAT) decreased glial fibrillary acidic protein (GFAP) staining in mice when administered 1min after CBDP and sarin while other 5-HT1A agonists buspirone and S-14506 were not effective. The reduction in GFAP staining by 8-OH-DPAT remained significant when a single dose was administered 2h after the toxic challenge. In addition, 8-OH-DPAT reversed the increase in the inflammatory factor IL-1β in the dentate gyrus and amygdala but did not reduce positive TUNEL staining in the dentate gyrus. Due to the failure of the two other agonists to provide protection, the 5-HT1A antagonist WAY-100635 was tested. WAY-100635 was found to neither reverse the neuroprotective effects of 8-OH-DPAT nor worsen the damage when given alone, making a role for this receptor unlikely. The neuroprotective effects of 8-OH-DPAT appear to lie within its secondary pharmacology.
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Contradictory evidence exists concerning the anxiolytic effects of 5-HT1A agonists in the conflict test. In the present work, a modification of the Vogel conflict model was used to assess different doses of diazepam (0.1-5.6 mg/kg), ipsapirone (1.0-17.8 mg/kg), buspirone (1.7-17.8 mg/kg), and indorenate (0.56-17.8 mg/kg) in rats receiving two different electric shock intensities (0.16 and 0.32 mA). The results show that the three 5-HT1A agonists had a smaller anticonflict effect than diazepam. The anticonflict effect with each compound was of a greater magnitude at 0.16 mA intensity than at 0.32 mA. This study shows that, using different electric shock intensities, compounds produce a differential effect: the anticonflict effects were more pronounced with the lower electric shock intensity than with the higher intensity. The present results suggest that the use of different shock intensities can play distinct roles over the drug's effect in the conflict test.
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Alprazolam, at doses double those generally recommended for anxiety disorders, appears to be as effective as tricyclic antidepressants (TCAs) in the acute treatment of mild to moderate MDD. Alprazolam was also found to have a more rapid onset of action than to TCAs, particularly for the improvement of anxiety, somatization, and insomnia. Two azapirones (buspirone and gepirone) also have demonstrated a modest acute antidepressant effect in preliminary studies, albeit only in a depressed outpatient sample with considerable anxiety at baseline. Finally, various antidepressant drugs (imipramine, trazodone, paroxetine) were shown to have, at the least, comparable efficacy to benzodiazepines (BZDs) in the acute treatment of GAD.
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To examine the effects of 1-(2-pyrimidinyl)-piperazine (1-PP), a buspirone metabolite, on bladder function in vivo.
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The effects of repeated treatment of rats with desipramine on 5-HT mechanisms within the nucleus accumbens (NAS) have been studied in a functional model. Local microinjections of 5-HT, quipazine as well as 5-HT1A receptor agonist buspirone, 8-OH-DPAT and NDO-008, inhibited rat locomotor activity in the open-field test. The effect of 5-HT and buspirone was blocked by serotonergic receptor antagonists methysergide and cyanopindolol, respectively. Chronic, but not acute treatment of rats with desipramine (10 mg/kg, PO, twice a day for 21 days, tests were performed 24 h after the last dose) significantly attenuated behavioral depression after 5-HT and quipazine microinjections, while the effect of buspirone was left unchanged. On the basis of present data, it may be concluded that whereas both accumbens 5-HT1A and 5-HT2 receptors appear to be important to regulation of animals' motility, only 5-HT2 receptors seem to be the most likely targets of antidepressive treatment. These data, along with previously reported changes in limbic noradrenergic and dopaminergic activity after antidepressive treatment, may explain the energizing influence of drugs and electroconvulsive shocks on psychomotor retardation, a part of endogenous depression.
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We identified 218 publications on pharmacological interventions in HD since 1965. Among them were 20 level-I, 55 level-II, 54 level-III trials, and 89 case reports. All these papers are listed and analyzed. Chorea was the primary end point in all level-I and level-II symptomatic intervention trials. There is some evidence for treating chorea with haloperidol or fluphenazine, and less evidence for olanzapine. These three drugs have been considered "possibly useful" for the treatment of chorea in this analysis. Other substances (e.g. amantadine, riluzole, and tetrabenazine) are considered "investigational" for chorea. There is very low evidence for the treatment of other problems: "possibly useful" drugs are L-dopa and pramipexole for rigidity; amitryptiline and mirtazapine for depression; risperidone for psychosis; and olanzapine, haloperidol, and buspirone for behavioral symptoms in HD. Three substances are considered "investigational" for possible neuroprotection: coenzyme Q10, minocycline, and unsaturated fatty acids.
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The behavioral effects of several new anxiolytics and putative anxiolytics were evaluated in two tests sensitive for anxiolytic activity. In the first test, rats were trained to lever-respond for sweetened milk under a multiple variable-interval fixed-ratio (VI-FR) schedule of reinforcement. In the FR component a brief electric shock coincided with the presentation of reward (i.e. conflict procedure). Treatment of these rats with diazepam, tracazolate, CGS-9896, and the pyrimidinylpiperazine derivatives buspirone, gepirone and ipsapirone (TVX Q 7821) significantly increased responding that was suppressed by foot-shock. A common metabolite of the pyrimidinylpiperazines, l-PP, had no affect on punished responding. A second group of rats was trained to discriminate diazepam from saline using a two-lever operant choice procedure. Diazepam-stimulus generalization occurred to CGS-9896, CL 218,872, zopiclone and tracazolate, but not to buspirone, gepirone, ipsapirone or l-PP. It was concluded that while all of the new compounds examined appear to share an anxiolytic effect as demonstrated by their activity in the conflict procedure, the pyrimidinylpiperazine agents do not share discriminative stimulus properties which are common to drugs which act via the benzodiazepine receptor.
Anxiety-related disorders are among the most common mental illnesses in the world for which benzodiazepines, buspirone and antidepressant drugs remain the first-line treatment. These drugs have good efficacy but they have numerous disadvantages, such as drug abuse potential, delayed onset of action or tolerance. A literature review reveals that a variety of piperazine derivatives may exhibit interesting pharmacological properties, including anxiolytic-like, antidepressant, nootropic and antinociceptive activities demonstrated in animal models, as well as an antioxidant capacity shown in some in vitro tests. Hence, the aim of this study was the synthesis and preliminary pharmacological in vivo evaluation of a novel N-cycloalkyl-N-benzoylpiperazine derivative, compound 9.
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In this randomized, double-blind, parallel-group, placebo-controlled trial of 60 healthy adults, we assessed the effects of oral venlafaxine, 150 mg; buspirone, 20 mg; and placebo on colonic sensorimotor functions.
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In recent years several arylpiperazine derivatives have reached the stage of clinical application, mainly for the treatment of depression, psychosis or anxiety. Examples are the pyrimidinylpiperazine buspirone, the chlorophenylpiperazine derivatives nefazodone and trazodone, the dichlorophenylpiperazine aripiprazole and the benzisothiazolyl derivatives perospirone and ziprasidone. Most of them undergo extensive pre-systemic and systemic metabolism including CYP3A4-dependent N-dealkylation to 1-aryl-piperazines. These metabolites are best known for the variety of serotonin receptor-related effects they cause in man and animals, although some have affinity for other neurotransmitter receptors; others, however, are still largely unexplored despite uncontrolled use as amphetamine-like designer drugs. Once formed they distribute extensively in tissues, including brain which is the target site of most arylpiperazine derivatives, and are then primarily biotransformed by CYP2D6-dependent oxidation to hydroxylates which are excreted as conjugates; only 1-(2-benzisothiazolyl)-piperazine is more susceptible to sulfur oxidation than to aromatic hydroxylation. In studies analysing animal brain and human blood, 1-aryl-piperazine concentrations were either higher or lower than the parent compound(s), although information is available only for some derivatives. At steady state, the metabolite-to-parent drug ratios varied widely among individuals taking the same dosage of the same arylpiperazine derivative. This is consistent with the known individual variability in the expression and activity of CYP3A4 and CYP2D6. This review also surveys current published information on physiological and pathological factors affecting the 1-aryl-piperazine-to-parent drug ratios and examines the potential role of 1-aryl-piperazine formation in the pharmacological actions of the arylpiperazine derivatives that are already or will shortly be available in major markets.
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This revision of previous algorithms for the pharmacotherapy of generalized anxiety disorder was developed by the Psychopharmacology Algorithm Project at the Harvard South Shore Program. Algorithms from 1999 and 2010 and associated references were reevaluated. Newer studies and reviews published from 2008-14 were obtained from PubMed and analyzed with a focus on their potential to justify changes in the recommendations. Exceptions to the main algorithm for special patient populations, such as women of childbearing potential, pregnant women, the elderly, and those with common medical and psychiatric comorbidities, were considered. Selective serotonin reuptake inhibitors (SSRIs) are still the basic first-line medication. Early alternatives include duloxetine, buspirone, hydroxyzine, pregabalin, or bupropion, in that order. If response is inadequate, then the second recommendation is to try a different SSRI. Additional alternatives now include benzodiazepines, venlafaxine, kava, and agomelatine. If the response to the second SSRI is unsatisfactory, then the recommendation is to try a serotonin-norepinephrine reuptake inhibitor (SNRI). Other alternatives to SSRIs and SNRIs for treatment-resistant or treatment-intolerant patients include tricyclic antidepressants, second-generation antipsychotics, and valproate. This revision of the GAD algorithm responds to issues raised by new treatments under development (such as pregabalin) and organizes the evidence systematically for practical clinical application.
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In the evaluation of treatment-resistant or treatment-refractory depression (TRD), true resistance to antidepressant therapy must be distinguished from inadequate dose, duration, or compliance with past antidepressant therapy. Reassessment of the diagnosis may reveal psychiatric comorbidity, the presence of depressive subtypes, or the possibility of a medical etiology. Management of TRD should consider patient-specific factors; drug therapy may be directed by depressive subtype or the presence of psychiatric comorbidity. Increasing the dose or duration of current antidepressant therapy is appropriate for patients who have received inadequate therapy in the past. Augmentation of tricyclic antidepressant (TCA) or selective serotonin reuptake inhibitor (SSRI) therapy with thyroid hormone (T3) or lithium has been shown to be effective in open and controlled trials. Efficacy of other strategies such as higher-dose antidepressant treatment, venlafaxine therapy, combined antidepressant therapy, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or augmentation with pindolol or buspirone has been less well established, but emerging data from open studies and case reports are encouraging.
The HAM-A and BSA items that most closely corresponded to DSM-IV diagnostic criteria for GAD showed the largest improvement during treatment with venlafaxine XR. This indicates that the specific symptoms of GAD can be treated effectively with venlafaxine XR, both in the short and longer term.
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Anxiolytic drugs are adjuncts to non-pharmacological treatments for anxiety. Alcohol and tobacco remain the major psychoactive agents that are used in our community. Benzodiazepine drugs are the agents of choice if an acute reduction in anxiety or intermittent therapy is needed and are helpful for long-term use in a few patients. For panic disorders, alprazolam is effective for short- and long-term treatment, although it needs a slow reduction in dosage and carries a risk of withdrawal reactions in about 30% of sufferers. Clonazepam also may help panic attacks and possibly other benzodiazepine agents would show similar effects at equivalent doses. Antidepressant drugs, including monoamine-oxidase inhibitor agents, although more toxic and sometimes less tolerated than is alprazolam, have antipanic effects in high doses and are of use for prolonged therapy for panic disorders. Neuroleptic agents' general usefulness as anxiolytic drugs is restricted because of their acute and long-term toxicity. There is no place for the use of antidepressant or neuroleptic drugs as treatments of first choice in uncomplicated generalized anxiety. beta-blocking agents have limited adjunctive use for performance anxiety and social phobias. Buspirone heralds a new class of anxiolytic agents. Buspirone has advantages in patients who can tolerate its slow onset of action, with reduced psychomotor effects, lower interactive effects with cortical depressant substances and a seeming lack of dependency or any withdrawal syndrome.
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This paper reviews the biochemical and behavioural evidence that the increased anxiety that occurs during benzodiazepine withdrawal is caused by increased 5-HT activity. In hippocampal slices taken from rats withdrawn for 24 h from chronic diazepam treatment (2 mg/kg/day for 21 days) there was a significant increase in K(+)-evoked release of [3H]5-HT and in 45Ca2+ uptake and both of these changes were reversed by the GABAB agonist, baclofen. Baclofen also reversed the anxiogenic response that is detected on withdrawal from chronic diazepam treatment. Other drugs that reduce 5-HT function (tianeptine which increases 5-HT uptake; buspirone, a 5-HT1A receptor agonist/partial agonist; zacopride, a 5-HT3 receptor antagonist) also reversed this anxiogenic response. Finally, we present data from a group of rats that did not develop tolerance to the anxiolytic effects of diazepam (2 mg/kg), even after 5 weeks treatment. This group failed to show an anxiogenic response on withdrawal from diazepam, nor was there an increase in hippocampal 5-HT release. We discuss the extent to which increased hippocampal 5-HT release can be causally linked to the increased anxiety during benzodiazepine withdrawal.