Olanzapine Versus Placebo in the Treatment of Adolescents With Bipolar Mania

Tohen, Mauricio; Kryzhanovskaya, Ludmila; Carlson, Gabrielle A.; DelBello, Melissa P.; Wozniak, Janet; Kowatch, Robert A.; Wagner, Karen Dineen; Findling, Robert L.; Lin, Daniel; Robertson-Plouch, Carol; Xu, Wen; Dittmann, Ralf W.; Biederman, Joseph

doi:10.1176/appi.ajp.2007.06111932

Cited by 264 publications

(152 citation statements)

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“…Methodologically rigorous controlled studies are awaited to confirm the efficacy of those mood stabilizers. Placebo-controlled evidence for the efficacy of other atypical antipsychotics, in addition to quetiapine, for the treatment of depressive symptoms in pediatric bipolar disorder, is also limited (Tohen et al 2007). …”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Findling

Pathak

Earley³

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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Objective: Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania. Large, placebo-controlled studies of interventions in pediatric bipolar depression are lacking. The current study investigated the efficacy and safety of quetiapine extended-release (XR) in patients 10-17 years of age, with acute bipolar depression. Methods: This multicenter, double-blind, randomized, placebo-controlled study investigated quetiapine XR (dose range, 150-300 mg/day) in pediatric outpatients with an American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I or bipolar II disorder (current or most recent episode depressed) treated for up to 8 weeks (ClinicalTrials.gov identifier: NCT00811473). The primary study outcome was mean change in Children's Depression Rating Scale-Revised (CDRS-R) total score. Secondary efficacy outcomes included CDRS-R-based response and remission rates. Results: Of 193 patients randomized to treatment, 144 patients completed the study (75.3% of quetiapine XR group [n = 70]; 74.0% of placebo group [n = 74]). Least squares mean changes in CDRS-R total score at week 8 were: -29.6 (SE, 1.65) with quetiapine XR and -27.3 (SE, 1.60) with placebo, a between-treatment group difference of -2.29 (SE, 1.99; 95% CI, -6.22, 1.65; p = 0.25; mixed-model for repeated measures analysis). Rates of response and remission did not differ significantly between treatment groups. The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release (IR). Potentially clinically significant elevations in clinical chemistry values included triglycerides (9.3%, quetiapine XR; 1.4%, placebo group) and thyroid stimulating hormone (4.7%, quetiapine XR; 0%, placebo group). An adverse event potentially related to diabetes mellitus occurred in 3.3% of the quetiapine XR versus no adverse events in the placebo group. Conclusions: Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression. Quetiapine XR was generally safe and well tolerated.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Findling

Pathak

Earley³

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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“…Due to safety and tolerability concerns, olanzapine (level 2)590 and ziprasidone (level 2)591 should be considered second‐line options. Quetiapine adjunctive therapy (level 3)592 is also recommended as a second‐line treatment.…”

Section: Specific Populationsmentioning

confidence: 99%

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

et al. 2018

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The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third‐ line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment‐emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second‐ line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence‐based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first‐line treatments for acute mania. First‐line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first‐line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe.

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“…Çocuk ve ergenlerde akut dönem tedavisinde şimdiye kadar plasebodan üstün bulunan ilaçlar olanzapin, risperidon, ketiyapin ve aripiprazoldur. [3][4][5][6] Mevcut birçok çalışmada, çocuk ve ergenlerde bipolar bozukluk tip I manik ve karma atakta valproatın etkinliği araştırılmıştır. Bir çalışmada 4 hafta süreli valproat tedavisi etkin bulunmamıştır.…”

Section: çOcuk Ve Ergenlerde Akut Mani Tedavisiunclassified

“…Sonuç olarak çocuklardaki manik veya karma ataklarda depresif belirtilerin akut tedavisinde olanzapin etkili değildir gibi gözükmektedir. [47] Benzer şekilde manik veya karma atağı olan 150 çocuk ve ergende valproat tedavisi ile plasebo kıyaslanmış, depresif belirtilerdeki değişiklik bakımından gruplar arasında anlamlı bir fark bulunamamıştır. [48] Diğer bir çalışmada 116 ergende okskarbamazepin ile yine plasebodan farklı klinik yanıt elde edilememiştir.…”

Section: çOcuk Ve Ergenlerde Bipolar Depresyon Tedavisiunclassified

Treatment of Pediatric Bipolar Disorder

Erdoğan¹,

Kurban²,

Yalcin³

2014

Psikiyatride Guncel Yaklasimlar - Current Approaches in Psychia

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ÖzetÖnceleri pediatrik bipolar bozukluk çok nadir görülen bir psikiyatrik bozukluk olarak düşünülse de, son 20 yıldaki araştırmalar bozukluğun sanılandan çok daha yaygın olduğunu ortaya koymuştur. Çocuk ve ergenlik başlangıçlı bipolar bozukluk ciddi ailesel ve akademik sorunlara, daha sık madde kullanımına, riskli cinsel ilişkilere, ergen gebeliği ve suça yatkınlığa neden olmaktadır. Erişkin başlangıçlıya göre yaşam boyu daha kötü bir işlevsellik söz konusudur. Tanı konulması daha güç olabilmekte ve tanı konulana kadar geçen süre erişkin bipolar bozukluğuna göre daha uzun olabilmektedir. Bu yaş grubunun özelliklerinden dolayı tedavi uyumu ile ilişkili problemlere daha sık rastlanmaktadır. Pediatrik bipolar bozukluktaki bu tanı ile ilgili karmaşa, tedavi konusunda da anlaşmazlıklara yol açmıştır. Bu gözden geçirmede çocuk ve ergenlik başlangıçlı bipolar bozukluktaki tedavi yaklaşımları ele alınmıştır. AbstractAlthough once pediatric bipolar disorder had been perceived as a very rarely seen psychiatric disorder, studies conducted within the last two decades revealed that this disorder is more often than assumed. Childhood and adolescent onset bipolar disorder causes and leads serious familial and academic disturbances, more frequent subtance use, precarios sexual intercourses, adolescent pregnancy and tendency to delinquency. Lifelong functionality is worse than adult onset. It could be more difficult to be diagnosed and could take longer time period for the diagnosis than adult onset. Difficulties of compliance to treatment can be seen more frequently because of the behavioural age characteristics of this group. Diagnostic controversies about the pediatric bipolar disorder also led disagreement about the treatment. In this review treatment approaches in the child and adolescent onset bipolar disorder have been discussed.

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Olanzapine Versus Placebo in the Treatment of Adolescents With Bipolar Mania

Abstract: Olanzapine was effective in the treatment of bipolar mania in adolescent patients. Patients treated with olanzapine, however, had significantly greater weight gain and increases in the levels of hepatic enzymes, prolactin, fasting glucose, fasting total cholesterol, and uric acid.

Cited by 264 publications

References 38 publications

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Efficacy and Safety of Extended-Release Quetiapine Fumarate in Youth with Bipolar Depression: An 8 Week, Double-Blind, Placebo-Controlled Trial

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

Treatment of Pediatric Bipolar Disorder

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