Treating Disruptive Behavior Disorders with Risperidone: A 1-Year, Open-Label Safety Study in Children and Adolescents

Haas, Magali; Karcher, Keith; Pandina, Gahan

doi:10.1089/cap.2007.0098

Cited by 26 publications

(16 citation statements)

References 22 publications

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“…As the five long-term (1–3 year) follow-up trials suggest, a low dose of risperidone (mean dose ranged from 1.38–1.92 mg/day) was equally well tolerated and effective in controlling the DBD and aggressive behaviors in this population 40,60,143,144,167 . Low dose risperidone (0.02 mg/kg/day) is also reported to be well tolerated and efficacious in treating DBD behaviors in youth with normal intelligence as suggested by short and long-termtrials 79,143 .…”

Section: Oppositional Defiant Disordermentioning

confidence: 99%

Comorbidity in Pediatric Bipolar Disorder

Joshi

Wilens

2009

Child and Adolescent Psychiatric Clinics of North America

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Synopsis A growing literature shows the pervasiveness and importance of comorbidity in youth with bipolar disorder (BPD). For instance, up to 90% of youth with BPD have been described to manifest comorbidity with attention deficit hyperactivity disorder. Multiple anxiety, substance use, and disruptive behavior disorders are the other most commonly reported comorbidities with BPD. Moreover, important recent data highlights the importance of obsessive compulsive and pervasive developmental illness in the context of BPD. Data suggests that not only special developmental relationships are operant in context to comorbidity, but also that the presence of comorbid disorders with BPD results in a more severe clinical condition. Moreover, the presence of comorbidity has therapeutic implications for the treatment response for both BPD and the associated comorbid disorder. Future longitudinal studies to address the relationship and the impact of comorbid disorders on course and therapeutic response over time are required in youth with BPD.

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Section: Oppositional Defiant Disordermentioning

confidence: 99%

Comorbidity in Pediatric Bipolar Disorder

Joshi

Wilens

2009

Child and Adolescent Psychiatric Clinics of North America

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“…Given these characteristics, psychopharmacological treatment was deemed necessary in these subjects. There are growing numbers of studies reporting that risperidone, an atypical antipsychotic medication, has been effective in the treatment of DBDs in school aged children and adolescents with normal or subaverage intelligence (14)(15)(16)(17)(18)(19)(20)(21). Risperidone is recommended as the first medication choice for treating children with DBD with severe aggression (1,22).…”

Section: Discussionmentioning

confidence: 99%

“…Risperidone, being the oldest atypical antipsychotic on the market, has been studied more extensively than the newer medications. There are both short-term, controlled clinical trials (14)(15)(16), and longerterm open-label trials (17)(18)(19)(20)(21) demonstrating benefit with risperidone treatment in children with DBDs with normal or subaverage intelligence; however, data regarding the use of atypical antipsychotics in preschool children are limited in the literature. Despite there is no clear consensus on the treatment of preschool children with psychiatric disorders, including DBDs, the primary treatment modality for most very young children is generally psychotherapeutic rather than psychopharmacological (22).…”

Section: Introductionmentioning

confidence: 99%

Risperidone treatment in preschool children with disruptive behavior disorders: a chart review study / Yıkıcı davranış bozuklukları olan okulöncesi çocuklarda risperidon tedavisi: Bir dosya tarama çalışması

Coşkun¹,

Zoroğlu

Öztürk³

2011

Klinik Psikofarmakoloji

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Yıkıcı davranış bozuklukları olan okulöncesi çocuklarda risperidon tedavisi: Bir dosya tarama çalışması Amaç: Normal gelişim gösteren okul öncesi çocuklarda yıkıcı davranış bozukluklarının (YDB) tedavisinde risperidonun etkinliği ve güvenilirliğine dair veri toplamak. Yöntem: Bu çalışma bir üniversite hastanesi ya da özel bir çocuk psikiyatrisi kliniğine başvuran/yönlendirilen ve YDB nedeniyle risperidon tedavisi alan okul öncesi çocukların tıbbi kayıt ve takiplerinin geriye dönük incelemesidir. Olguların tıbbi kayıtları psikiyatrik özellikler ve risperidon tedavisinin etkinliği ve ilişkili yan etkiler açısından incelendi. Semptom şiddeti ve iyileşme Klinik Global İzlem-Şiddet (KGİ-Ş) ve İyileşme (KGİ-İ) ölçekleri kullanılarak değerlendirildi. Bulgular: Olgular 21 erkek (%84) ve 4 kız çocuğundan (%16) oluşmaktaydı. Yaş ortalaması 45.79±11 aydı. Risperidon tedavisinin süresi 2-60 haftaydı (18.87±15.19). Risperidon doz aralığı 0.25-1 mg/gündü (0.52±0.22 mg). Başlangıç ve son-değerlendirme KGİ-Ş skorları sırasıyla 6-7 (6.56±0.5) ve 2-7 (3.96±1.3) idi. Wilcoxon t-testi başlangıç ve son-değerlendirme KGİ-Ş puanları arasında belirgin bir farklılık gösterdi (p<0.001). Olguların önemli bir kısmı (n=18; %72) hedef yıkıcı davranış semptomlarında oldukça ya da çok düzelme gösterdi. Beş olgu (%20) her hangi bir yan etki bildirmedi. En sık bildirilen yan etkiler sedasyon, iştah artışı, kilo artışı, enuresis, baş ağrısı, dermatolojik reaksiyonlar ve yorgunluk olarak saptandı. Yan etkiler genel olarak geçici ve hafif-orta şiddetliydiler. Dört olgu yan etkilerden dolayı tedaviyi bıraktı. Her hangi bir yaşam-tehdit edici yan etki bildirilmedi. Sonuç: Psikososyal girişimler YDB olan okul öncesi çocuklarda ilk sıra tedavi olmalıdır. Ciddi derecede etkilenmiş olgularda psikofarmakolojik tedavi dikkatli bir takiple bir tedavi seçeneği olabilir. Risperidon YDB olan okul öncesi çocuklarda genel olarak güvenli ve etkili bir farmakolojik tedavi seçeneği olabilir. Bununla birlikte yüksek yan etki oranları bu konuda karar verilirken dikkatli olmayı gerektirmektedir. Bu konuda daha iyi dizayn edilmiş sistematik araştırmalara ihtiyaç vardır.

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“…AEs of particular interest include extrapyramidal symptoms (EPS), somnolence/fatigue, weight gain, effects on glucose and lipid metabolism, prolactin elevation and potentially prolactin-related AEs, and the potential for effects on growth and sexual maturation. Although several studies have previously documented the safety and tolerability of risperidone in disruptive behavior disorders over a period of 1 year or longer [15,16], data on the long-term safety and tolerability of risperidone in adolescents with schizophrenia are more limited.…”

Section: Introductionmentioning

confidence: 99%

An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

Pandina

Kushner

Karcher

et al. 2012

Child Adolesc Psychiatry Ment Health

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BackgroundData on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia.MethodsThis open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE) monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales.ResultsA total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7%) subjects completed this study: 209 of the 279 subjects (75%) in the 6-month group and 55 of the 111 subjects (50%) in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects) were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs) were reported by 36 (9%) subjects. The AE profile in this study was qualitatively similar to those of other studies in adult subjects with schizophrenia and in other psychiatric studies of risperidone in pediatric populations.ConclusionsRisperidone maintenance treatment in adolescents over 6 to 12 months was well tolerated, consistent with related studies in this clinical population, and associated with continued efficacy.Clinical trialsClinicalTrials.gov registration number: NCT00246285 http://clinicaltrials.gov/ct2/show/NCT00246285?term=NCT00246285&rank=1

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Treating Disruptive Behavior Disorders with Risperidone: A 1-Year, Open-Label Safety Study in Children and Adolescents

Abstract: Risperidone reinitiated for DBD in children with normal intelligence quotients (IQ) was safe and well tolerated over an additional year of treatment. Patients demonstrated clinical benefits, including those who previously experienced symptom recurrence.

Cited by 26 publications

References 22 publications

Comorbidity in Pediatric Bipolar Disorder

Comorbidity in Pediatric Bipolar Disorder

Risperidone treatment in preschool children with disruptive behavior disorders: a chart review study / Yıkıcı davranış bozuklukları olan okulöncesi çocuklarda risperidon tedavisi: Bir dosya tarama çalışması

An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

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