Controlled Study of Pimozide vs. Placebo in Tourette's Syndrome

Shapiro, Arthur M.; Shapiro, Elaine

doi:10.1097/00004583-198403000-00007

Cited by 176 publications

(66 citation statements)

References 16 publications

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“…99 In another mixed study, 20 participants underwent a crossover trial of maximum dose of 20 mg/day (10 mg/day for children aged ≤ 10 years) pimozide compared with placebo for 6 weeks each. 100 In another mixed crossover study, nine participants underwent treatment with maximum dose of 12 mg/day haloperidol and pimozide in a randomised order for 12 days each. 106 Two studies compared risperidone with placebo.…”

Section: Study Characteristicsmentioning

confidence: 99%

Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis

Hollis

Pennant

Cuenca

et al. 2016

Health Technol Assess

126

109

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BackgroundTourette syndrome (TS) is a neurodevelopmental condition characterised by chronic motor and vocal tics affecting up to 1% of school-age children and young people and is associated with significant distress and psychosocial impairment.ObjectiveTo conduct a systematic review of the benefits and risks of pharmacological, behavioural and physical interventions for tics in children and young people with TS (part 1) and to explore the experience of treatment and services from the perspective of young people with TS and their parents (part 2).Data SourcesFor the systematic reviews (parts 1 and 2), mainstream bibliographic databases, The Cochrane Library, education, social care and grey literature databases were searched using subject headings and text words for tic* and Tourette* from database inception to January 2013.Review/research methodsFor part 1, randomised controlled trials and controlled before-and-after studies of pharmacological, behavioural or physical interventions in children or young people (aged < 18 years) with TS or chronic tic disorder were included. Mixed studies and studies in adults were considered as supporting evidence. Risk of bias associated with each study was evaluated using the Cochrane tool. When there was sufficient data, random-effects meta-analysis was used to synthesize the evidence and the quality of evidence for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. For part 2, qualitative studies and survey literature conducted in populations of children/young people with TS or their carers or in health professionals with experience of treating TS were included in the qualitative review. Results were synthesized narratively. In addition, a national parent/carer survey was conducted via the Tourettes Action website. Participants included parents of children and young people with TS aged under 18 years. Participants (young people with TS aged 10–17 years) for the in-depth interviews were recruited via a national survey and specialist Tourettes clinics in the UK.ResultsFor part 1, 70 studies were included in the quantitative systematic review. The evidence suggested that for treating tics in children and young people with TS, antipsychotic drugs [standardised mean difference (SMD) –0.74, 95% confidence interval (CI) –1.08 to –0.41;n = 75] and noradrenergic agents [clonidine (Dixarit®, Boehringer Ingelheim) and guanfacine: SMD –0.72, 95% CI –1.03 to –0.40;n = 164] are effective in the short term. There was little difference among antipsychotics in terms of benefits, but adverse effect profiles do differ. Habit reversal training (HRT)/comprehensive behavioural intervention for tics (CBIT) was also shown to be effective (SMD –0.64, 95% CI –0.99 to –0.29;n = 133). For part 2, 295 parents/carers of children and young people with TS contributed useable survey data. Forty young people with TS participated in in-depth interviews. Four studies were in the qualitative review. Key themes were difficulties in accessing specialist care and behavioural interventions, delay in diagnosis, importance of anxiety and emotional symptoms, lack of provision of information to schools and inadequate information regarding medication and adverse effects.LimitationsThe number and quality of clinical trials is low and this downgrades the strength of the evidence and conclusions.ConclusionsAntipsychotics, noradrenergic agents and HRT/CBIT are effective in reducing tics in children and young people with TS. The balance of benefits and harms favours the most commonly used medications: risperidone (Risperdal®, Janssen), clonidine and aripiprazole (Abilify®, Otsuka). Larger and better-conducted trials addressing important clinical uncertainties are required. Further research is needed into widening access to behavioural interventions through use of technology including mobile applications (‘apps’) and video consultation.Study registrationThis study is registered as PROSPERO CRD42012002059.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Study Characteristicsmentioning

confidence: 99%

Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis

Hollis

Pennant

Cuenca

et al. 2016

Health Technol Assess

126

109

View full text Add to dashboard Cite

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“…Six RCTs have been conducted on the use of pimozide for tics. [8][9][10][11][12][13] These trials were included in a recent Cochrane systematic review 14 that received an AMSTAR score of 9 (out of 11). A meta-analysis of study results was not possible because of methodological concerns and clinical heterogeneity.…”

Section: Antipsychotics For the Treatment Of Ticsmentioning

confidence: 99%

“…Mean dosages of pimozide ranged from 2.4 to 12.0 mg/day. Pimozide was compared with placebo alone, 8 haloperidol alone, 13 both placebo and haloperidol, 9,12 and risperidone. 10,11 The methodological quality of each of the 6 RCTs was fair.…”

Section: Antipsychotics For the Treatment Of Ticsmentioning

confidence: 99%

Canadian Guidelines for the Evidence-Based Treatment of Tic Disorders: Pharmacotherapy

et al. 2012

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This article seeks to provide the practising clinician with guidance on the pharmacological management of tic disorders in children and adults. We performed a systematic review of the literature on the treatment of tic disorders. A multi-institutional group of 14 experts in psychiatry, child psychiatry, neurology, pediatrics, and psychology engaged in a consensus meeting. The evidence was presented and discussed, and nominal group techniques were employed to arrive at consensus on recommendations. A strong recommendation is made when the benefits of treatment clearly outweigh the risks and burdens, and can apply to most patients in most circumstances without reservation. With a weak recommendation, the benefits, risks, and burdens are more closely balanced, and the best action may differ depending on the circumstances. Based on these principles, weak recommendations were made for the use of pimozide, haloperidol, fluphenazine, metoclopramide (children only), risperidone, aripiprazole, olanzapine, quetiapine, ziprasidone, topiramate, baclofen (children only), botulinum toxin injections, tetrabenazine, and cannabinoids (adults only). Strong recommendations were made for the use of clonidine and guanfacine (children only). While the evidence supports the efficacy of many of the antipsychotics for the treatment of tics, the high rates of side effects associated with these medications resulted in only weak recommendations for these drugs. In situations where tics are not severe or disabling, the use of a medication with only a weak recommendation is not warranted. However, when tics are more distressing and interfering, the need for tic suppression to improve quality of life is stronger, and patients and clinicians may be more willing to accept the risks of pharmacotherapy.

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“…This study reported no ECG abnormalities with the use of pimozide. However, an early randomized, controlled trial by Shapiro and Shapiro (1984) showed that pimozide was the agent most related to prolongation of the QTc interval. Findings are mixed, as a later study suggested that although QTc interval can be prolonged with use, it is not generally in the abnormal range [Shapiro et al 1989].…”

Section: Pharmacological Treatments For Ticsmentioning

confidence: 99%

Treatment strategies for tics in Tourette syndrome

Eddy

Rickards

Cavanna

2010

Ther Adv Neurol Disord

144

106

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Tourette syndrome (TS) is a chronic neurodevelopmental disorder characterized by tics: repetitive, involuntary movements and vocalizations. These symptoms can have a significant impact on patients' daily functioning across many domains. Tics tend to be most severe in child and adolescent sufferers, so their presence has the potential to impact a period of life that is both critical for learning and is often associated with the experience of greater social tension and self-consciousness than adulthood. Furthermore, control over tics that lead to physical impairment or self-injurious behaviour is of vital importance in maintaining health and quality of life. There are numerous complicating factors in the prescription of treatment for tics, due to both the side effects associated with alleviating agents and patient characteristics, such as age and comorbid conditions. This review summarizes literature pertaining to the efficacy and safety of both traditionally prescribed and more modern medications. We also discuss the merits of behavioural and surgical techniques and highlight newer emerging treatments. Although treatment response is to some extent variable, there are a number of agents that are clearly useful as first-line treatments for TS. Other interventions may be of most benefit to patients exhibiting refractory tics or more specific symptom profiles.

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Controlled Study of Pimozide vs. Placebo in Tourette's Syndrome

Cited by 176 publications

References 16 publications

Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis

Clinical effectiveness and patient perspectives of different treatment strategies for tics in children and adolescents with Tourette syndrome: a systematic review and qualitative analysis

Canadian Guidelines for the Evidence-Based Treatment of Tic Disorders: Pharmacotherapy

Treatment strategies for tics in Tourette syndrome

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