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Use of Antipsychotics in Children and Adolescents Use of Antipsychotics in Children and Adolescents Use of Antipsychotics in Children and Adolescents Robert L. Findling, M.D.; Hans Steiner, M.D.; and Elizabeth B. Weller, M.D. The comparable efficacy and improved safety of the atypical antipsychotics compared with the traditional antipsychotic agents in the treatment of schizophrenia and other disorders in adults have prompted the use of these agents in children and adolescents. The atypical antipsychotics are increas- ingly being used in children and adolescents with a variety of different psychiatric diagnoses, includ- ing schizophrenia, bipolar disorder, autism/pervasive developmental disorders, conduct disorder, de- pression, anxiety disorders, tic disorders, delirium, and eating disorders. Unfortunately, clinical use of these agents in pediatric patients has far exceeded the limited evidence from randomized controlled trials. This article reviews the available evidence from the published literature on the use of the atypi- cal antipsychotics in children and adolescents with schizophrenia, bipolar disorder, and maladaptive aggression associated with autism/pervasive developmental disorders and conduct disorder/disruptive behavior disorders. (J Clin Psychiatry 2005;66[suppl 7]:29–40) n the early 1990s, the antipsychotics were the most scarce. Because the disorders for which the atypical I commonly prescribed pharmacologic agents for child antipsychotics are used are generally chronic, severe, and and adolescent psychiatric inpatients.1 Since then, the role disabling, it is extremely important that double-blind, of the antipsychotics, particularly the atypical antipsy- placebo-controlled data become available in order to pro- chotics, has expanded and now includes more outpatients vide clinically meaningful information about efficacy and and children and adolescents with a variety of psychiatric safety. This article will consider the extant data regarding disorders. Besides schizophrenia, bipolar disorder, aggres- the use of antipsychotics in the treatment of schizophrenia, sive/disruptive behavior, depression, anxiety disorders, tic bipolar disorder, and aggression in pediatric patients. disorders, delirium, and eating disorders are examples of conditions for which clinicians are prescribing the atypical SCHIZOPHRENIA antipsychotics.2 Despite the increased use of the atypical antipsy- The onset of schizophrenia often occurs in adolescence, chotics, data supporting their use in children and adoles- with many patients experiencing their first psychotic epi- cents from randomized controlled trials are remarkably sode before the age of 15 years.3–6 Although childhood- onset schizophrenia is much less common than the adolescent-onset illness,7,8 psychotic illnesses also occur in prepubertal children.5 Childhood- and adolescent-onset From University Hospitals of Cleveland, Cleveland, Ohio schizophrenia is generally more severe and treatment- (Dr. Findling); Stanford University School of Medicine, refractory than adult-onset illness and has a poorer Stanford, Calif. (Dr. Steiner); and the University of 3,4,7,9 Pennsylvania, Philadelphia (Dr. Weller). prognosis. The symposium “Developmental Neurobiology and There are remarkably few randomized controlled trials Psychiatry: Challenges and Best Practices for Studies in Children and Adolescents” was held October 3–4, 2003, to inform treatment decisions for adolescent-onset schizo- in Henderson, Nev., and was sponsored by Otsuka phrenia.10,11 The information that is available is derived Pharmaceutical, Inc. largely from single case reports, retrospective case series, Dr. Findling has received grant/research support from and been a consultant for Abbott, AstraZeneca, Bristol-Myers chart reviews, and open-label studies. Although contem- Squibb, Celltech-Medeva, Forest, GlaxoSmithKline, Johnson & porary treatment is, out of necessity, guided by the find- Johnson, Eli Lilly, New River, Novartis, Otsuka, Pfizer, Shire, and Wyeth; has received grant/research support from Solvay; ings of studies in adults, adolescents may not respond to has been a consultant for Sanofi-Synthelabo; and has served treatment in the same manner as older patients. Young on the speakers bureau for Shire. Dr. Weller has been a consultant for Otsuka, AstraZeneca, Eli Lilly, people with schizophrenia are a particularly challenging GlaxoSmithKline, Shire, and Pharma and has received population to study and treat. Adolescents may respond grant/research support from the National Institute of Mental well to treatment for a period of time only to rapidly and Health, Otsuka, Johnson & Johnson, and AstraZeneca. 12 Corresponding author and reprints: Robert L. Findling, unexpectedly decompensate. Moreover, diagnosis can be M.D., Department of Psychiatry, Division of Child and difficult, and many adolescents with psychosis who are Adolescent Psychiatry, University Hospitals of Cleveland, Case Western Reserve University, 11100 Euclid Avenue, Cleveland, referred to specialty psychiatric care from mental health OH 44106-5080 (e-mail: [email protected]). clinicians do not fulfill diagnostic symptom criteria for J Clin Psychiatry 2005;66 (suppl 7) 29 Findling et al. schizophrenia.13 Nonetheless, schizophrenia in adoles- controlled study,21 2 open-label studies,22,23 and 1 retrospec- cents may respond to antipsychotic treatment, and the tive analysis of long-term treatment,24 all of which were atypical antipsychotics are increasingly being used in this conducted in treatment-refractory patients. In the short- age group.10,14–17 term controlled study, clozapine was compared with halo- peridol in a double-blind fashion in 21 adolescents with Antipsychotic Studies in Children schizophrenia.21 This population was severely ill and and Adolescents With Schizophrenia treatment-refractory with a mean ± SD age of 14 ± 2.3 Traditional antipsychotics. There are only 2 controlled years and an age at onset of less than 13 years. Patients studies of acute treatment with the older, “traditional” were randomly assigned to receive a 6-week course of flex- antipsychotics in adolescents with schizophrenia. Long- ible doses with either clozapine (mean dose = 176 mg) or term studies have not been conducted in this population. haloperidol (mean dose = 16 mg; with prophylactic benz- Of the 2 available trials, 1 was published nearly 30 tropine). Clozapine was superior to haloperidol across all years ago and remains the largest published, randomized, outcome measures and reduced both positive and negative placebo-controlled, double-blind study of any antipsy- symptoms. Although EPS did not occur in the clozapine- chotic, traditional or atypical, in adolescent patients. In treated patients, other adverse events associated with clo- this study, Pool and colleagues18 compared the efficacy zapine were of concern. Of the 10 patients in the clozapine and adverse effects of a 4-week, double-blind, placebo- group, neutropenia occurred in 4, seizures in 2, and seda- controlled trial of haloperidol (mean dose = 9.8 mg), loxa- tion in 9. One third of the clozapine-treated patients were pine (mean dose = 87.5 mg), or placebo in 75 adolescent withdrawn from the study because of adverse events. inpatients with schizophrenia. Both active treatments re- The efficacy and safety of long-term treatment sulted in significantly greater symptom improvement than with clozapine in 36 adolescents and young adults with placebo, but were associated with higher rates of extra- schizophrenia were assessed in a retrospective review.24 pyramidal symptoms (EPS) and sedation. Extrapyramidal This is the only published analysis of long-term treatment symptoms were observed in 73% of patients treated with with clozapine in the adolescent population. Patients haloperidol, 72% treated with loxapine, and 4% treated were treated with clozapine (mean dose = 330 mg; range, with placebo. Sedation occurred in 52% of patients in the 50–800 mg) for a mean duration of 154 days. Clinical re- haloperidol group, 81% in the loxapine group, and 25% sponse included marked improvement in 75% of patients in the placebo group. The second controlled study was a and remission in 11%. Adverse events consisted of leuko- single-blind, 4- to 6-week comparison of thiothixene and penia (3 patients), electroencephalographic (EEG) changes thioridazine treatment of 21 adolescents with schizo- (16 patients), akathisia (4 patients), and coarse tremor (1 phrenia (mean age = 14.6 years).19 Both antipsychotics patient). Six of the 36 patients discontinued treatment be- improved baseline Brief Psychiatric Rating Scale (BPRS) cause of adverse events, which included stupor, leukope- symptom scores. However, at study endpoint, most pa- nia, cardiotoxicity, and significant transaminase elevations. tients remained ill, with a mean BPRS score of 32.2. Rates On the basis of available data, clozapine appears to have of sedation (75%) and orthostasis (38%) were high with a role in treating adolescents with treatment-refractory thioridazine, as were rates of sedation (54%) and EPS schizophrenia. As in adults, however, caution must be (54%) for thiothixene. taken to monitor leukocyte counts. In addition, adolescents Clinical outcomes for schizophrenia, including thera- may be at increased risk of EEG abnormalities or seizures peutic response and adverse events, may in part be age- during clozapine therapy, and pretreatment electroenceph- related. For example, poor response to treatment with tra- alograms may be a reasonable consideration.10 ditional antipsychotics may be associated
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