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Objective: The purpose of this study was to assess change in body mass index (BMI) and age- and gender-adjusted BMI Z-score in subjects ages 2-20 years with autism spectrum disorders (ASD), who were treated longitudinally with risperidone or aripiprazole at a tertiary care ASD clinic., Method: As part of a larger project involving longitudinal drug treatment data in ASD, detailed demographic and treatment data were collected for 142 subjects ages 2-20 years who had been started on risperidone or aripiprazole for treatment of irritability. Mean age at start of treatment, treatment duration, final Clinical Global Impressions-Improvement Scale score, BMI change per year of treatment, and BMI Z-score change per year of treatment (primary outcome measure) were calculated for each drug treatment group. Group means were compared using t tests and Wilcoxon rank sum tests., Results: There was a statistically significant BMI and BMI Z-score increase in the risperidone and aripiprazole treatment groups individually. No statistically significant difference between the two treatment groups was noted in mean BMI change per year of treatment or BMI Z-score change per year of treatment., Conclusions: In our review of long-term naturalistic treatment of irritability using risperidone versus aripiprazole in persons with ASD, a significant increase in both BMI and age- and gender-adjusted BMI Z-score was noted for each treatment group. No significant difference in BMI or BMI Z-score change was noted when the two treatment groups were compared. We conclude that in our patient population at a tertiary care ASD clinic, the effects of risperidone and aripiprazole on body weight gain in naturalistic long-term treatment are no different., Competing Interests: Dr. Erickson received past research support from and was consultant to F. Hoffman-LaRoche, Novartis, and Seaside Therapeutics. He also received past research support from Bristol-Myers Squibb. Dr. Erickson is also a current equity holder in Confluence Pharmaceuticals. He receives current research support from Autism Speaks, the Cincinnati Hospital Research Foundation, the John Merck Fund, The Roche Group, the Simons Research Foundation, SynapDx, and the United States Department of Defense. His conflicts do not overlap with the content of this manuscript. Dr. Wink and Dr. Schaefer receive current research support from the Cincinnati Children's Hospital Research Foundation the John Merck Fund, The Roche Group, the Simons Research Foundation, Synapdx, and the United States Department of Defense. Dr. Horn is a 1% owner of Shiloh Pharma, LLC. Ms. Early, Ms. Pottenger, and Dr. McDougle acknowledge no current conflicts of interest.

Objective: The purpose of this study was to evaluate the impact of prior antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment., Methods: This study was a post-hoc analysis of pooled data from two 8-week, double-blind, randomized, placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder, aged 6-17 years. Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated. For subjects receiving aripiprazole, regardless of PAE, baseline weight, age, gender, and symptom severity were evaluated in a regression model predicting body weight change., Results: Of 316 randomized subjects, 259 (82.0%) were antipsychotic naïve (AN) and 57 (18.0%) had a PAE. Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence (11.9% vs. 2.8%), sedation (22.7% vs. 11.1%), or fatigue (17.0% vs. 13.9%). Rates of extrapyramidal disorder and drooling, but not akathisia or tremor, were marginally higher in AN subjects. Overall, 10.8% of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3% of aripiprazole-treated PAE subjects. AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo (1.9 vs. 0.7 kg; treatment difference 1.2 kg, 95% CI: 0.5, 1.9) than PAE subjects receiving aripiprazole compared with subjects receiving placebo (0.4 vs. -0.4 kg; treatment difference 0.9 kg, 95% CI: -0.6, 2.4). Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain. There were no significant changes in metabolic measures compared with placebo in either group., Conclusions: Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score. AN subjects were more likely to experience AEs related to somnolence. However, based on discontinuations rates from AEs, overall tolerability was good for both AN and PAE groups., Clinical Trial Registration: Study of aripiprazole in the treatment of children and adolescents with autistic disorder. Registry: www.clinicaltrials.gov . Identifiers: NCT00332241 and NCT00337571.

Objective: This study aimed to: document the extent of the reduction of serum prolactin (PRL) levels induced by aripiprazole (ARI) treatment in children and adolescents, compare this effect by age group, and shed light on this phenomenon., Methods: PRL serum levels in unmedicated subjects were compared to those in subjects treated with aripiprazole to calculate the rate of subnormal PRL levels during aripiprazole treatment. Next, a literature search was performed to better understand the effects of dopaminergic drugs on PRL levels by age group., Results: Sixty percent of those treated with aripiprazole exhibited subnormal PRL serum levels versus 8% of unmedicated subjects. The rate of PRL subnormality in response to aripiprazole was half as frequent in adolescents and was minimal in adults. The drug-induced reduction of PRL serum levels became more prominent with increasing doses of aripiprazole and with an increased treatment duration., Conclusions: With the increasing use of aripiprazole in the United States population, it is important that future research be conducted to explore the potential sequelae of subnormal PRL serum levels in children and adolescents.

Objectives: Psychotropic medications, including the atypical antipsychotics, have historically been scrutinized for cardiac effects and risk of sudden death. Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder. Adult studies have evaluated aripiprazole's effects on electrocardiograms, but no pediatric studies have been published to date., Methods: Electrocardiographic data were collected from children and adolescents participating in a 14-week, prospective, open-label study (n=25) of aripiprazole for irritability in pervasive developmental disorder not otherwise specified and Asperger's disorder. A 12-lead electrocardiogram was obtained at the baseline and end point visits. The electrocardiograms were evaluated for abnormal findings, and the PR, QRS, QT(c), and RR intervals were recorded. The QT interval was corrected using Bazett's, United States Food and Drug Administration (FDA) Pharmacology Division, and Fridericia's formulas., Results: Twenty-four subjects received both baseline and posttreatment electrocardiograms. The mean age was 8.6 years (range 5-17 years). The average final aripiprazole dose was 7.8 mg/day (range 2.5-15 mg/day). There were no significant differences noted with the PR, QRS, RR, and QT(c) intervals after aripiprazole therapy. Also, there was no significant correlation between the dose given and the percent change in the QT(c). No post-treatment QT(c) exceeded 440 ms., Conclusions: To our knowledge, this is the first systematic evaluation of the cardiac effects of aripiprazole in children and adolescents. The results are consistent with previously published literature in adults that aripiprazole has no significant cardiac effects and can be deemed a low risk for causing sudden death. It will be important to confirm these findings in a randomized controlled trial.

Tourette's disorder (TD) in children and adolescents is frequently co-morbid with attention-deficit/hyperactivity disorder (ADHD). Dopamine-blockers are the first line treatment for TD, whereas dopamine-agonists, such as stimulants, are the gold-standard in the treatment of ADHD. These contrasting effects supported concerns about the risk that stimulants for treating ADHD may trigger or worsen co-morbid tics. Aripiprazole, a partial dopamine agonist, acts as an antagonist at dopamine D2 receptors in hyperdopaminergic conditions and displays agonist properties under hypodopaminergic conditions. The present study describes the use of aripiprazole (10.0 ± 4.8 mg/day) in a consecutive group of 28 patients with a primary diagnosis of TD and co-morbid ADHD, combined subtype. The Yale Global Tic Severity Scale (YGTSS) and the ADHD-Rating Scale (ADHD-RS-IV) were used as primary outcome measures and both significantly improved (p<0.001) after the treatment. Global measures of severity (Clinical Global Impressions-Severity) and of functional impairment (Children's Global Assessment Scale) also significantly improved during the treatment (p<0.001). At the YGTSS there was a reduction of 42.5%, in motor tics, of 47.9% in phonic tics (44.7% for the combined scores), and of 32.3% in tic impairment. Nineteen patients (67.9%) had a reduction of at least 50% of the YGTSS score (motor+phonic tics). The improvement at the ADHD-RS-IV score was 22.5%, 12 patients (42.8%) presented an improvement of 30%, but only 2 (7.1%) an improvement greater than 50%. Using a logistic regression model, a reduction of at least 30% in ADHD-RS-IV score was more likely to occur in the obsessive-compulsive disorder co-morbid group. Aripiprazole was well tolerated and none of the patients discontinued medication because of side effects. In summary, aripiprazole resulted in an effective treatment for TD, but it was only moderately effective on co-occurring ADHD symptomatology. Our preliminary data suggest that aripiprazole may represent a possible therapeutic option, among other possible monotherapies addressing both tics and ADHD.

Objective: The purpose of this open-label study was to describe the effectiveness of aripiprazole (APZ) in the treatment of children with bipolar disorders suffering from manic symptomatology., Method: Symptomatic outpatients (Young Mania Rating Scale [YMRS] score ≥15) meeting strict, unmodified, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic symptom criteria for a bipolar disorder, ages 4-9 years, were eligible. Subjects were treated prospectively with flexible doses of APZ (maximum daily dose of 15 mg/day), for up to 16 weeks or until a priori response criteria were met. Outcome measures included the YMRS, Clinical Global Impressions Scale-Severity, Children's Global Assessment Scale (CGAS), and the Children's Depression Rating Scale-Revised (CDRS-R). A priori response criteria consisted of 3 of 4 consecutive weeks with (1) CDRS-R <29; (2) YMRS <10; and (3) CGAS >50., Results: Ninety-six children (62 males; mean age of 6.9 (SD = 1.7), received APZ for an average length of treatment of 12.5 (SD = 3.9) weeks. Significant improvements in YMRS, CDRS-R, CGAS, and Clinical Global Impressions Scale-Severity scores (p < 0.001) were noted at the end of study participation. Sixty of the subjects (62.5%) met a priori response criteria at study's end. The most common side effects noted were stomachache, increased appetite, and headache. Two subjects were removed from the study due to side effects [epistaxis (n = 1); akathisia (n = 1)]. Subjects experienced an average weight gain of 2.4 (SD = 1.9) kg., Conclusion: APZ may be effective in the acute treatment of symptoms of children with bipolar illnesses.

Objective: The aim of this study was to evaluate the effects of aripiprazole treatment on individual Young Mania Rating Scale (YMRS) line items in pediatric subjects with manic or mixed episodes associated with bipolar I disorder to better understand the discrete symptom improvements., Methods: This was a post hoc analysis of the YMRS line item data from a 4-week, multicenter, randomized, double-blind, placebo-controlled study. Two hundred ninety-six eligible subjects were randomized to aripiprazole 10 mg/day (n = 98), aripiprazole 30 mg/day (n = 99), or placebo (n = 99). The primary endpoint was the mean change in YMRS total scores from baseline to week 4. Effect sizes and treatment effect on individual line items were calculated., Results: Of the 296 subjects, 237 (80.1%) completed the 4-week study. Seven of the 11 YMRS line items showed a statistically significant improvement in both aripiprazole treatment groups versus placebo. Using the data for the pooled doses, the three YMRS line items with the greatest effect size at week 4 were irritability (effect size = 0.7; treatment effect = 1.43; p < 0.001), aggressive behavior (effect size = 0.7; treatment effect = 1.38; p < 0.001), and increased motor activity/energy (effect size = 0.6; treatment effect = 0.86; p < 0.001)., Conclusion: Aripiprazole improved a broad spectrum of symptoms across the YMRS scale.

Aim: To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder., Methods: This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score., Results: Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved)., Conclusion: Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.

Objectives: The aim of this study was to evaluate the efficacy of aripiprazole in the treatment of discrete symptoms of irritability associated with autistic disorder, as well as other symptoms captured on the Aberrant Behavior Checklist (ABC)., Methods: This was a post hoc analysis of data from two 8-week, randomized, double-blind, multicenter trials to evaluate the efficacy of aripiprazole dosed flexibly (2-15 mg/day, n=47) or fixed (5, 10, or 15 mg/day, n = 166) versus placebo (flexibly dosed, n = 51; fixed dose, n = 52). The effects of treatment on the 58 ABC items were evaluated., Results: Statistically significantly greater improvement was seen with aripiprazole versus placebo (p < 0.05) for all arms in both trials on the ABC-Irritability total subscale score and on the following individual ABC-Irritability items: Mood changes quickly, cries/screams inappropriately, and stamps feet/bangs objects. Several additional items measuring tantrum-like behaviors improved in the flexibly dosed trial and at least one arm of the fixed-dose trial (p < 0.05). Measures of self-injurious behavior, which had low baseline values, demonstrated numerical, but not statistically significant, improvement in both trials. Statistically significantly greater improvement in ABC Stereotypic Behavior and Hyperactivity total subscale scores was also consistent across all arms in both trials. In particular, there was a cluster of items related to hyperkinesis that were consistently sensitive to treatment., Conclusions: Aripiprazole is efficacious in the treatment of irritability in children and adolescents with autistic disorder, particularly with respect to symptoms associated with tantrum behavior.

Objective: The primary aim of the study was to evaluate the effectiveness and tolerability of aripiprazole on motor and vocal tics in children and adolescents with Tourette's disorder (TD). The secondary aim was to assess the response of TD-associated behaviors to aripiprazole exposure., Methods: This was an 8-week, open-label trial with flexible dosing strategy of aripiprazole in children and adolescents with TD. A total of 72 patients, aged 6-18 years, participated in the 8-week trial. The Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impressions-Tics (CGI-Tics), and the Child Behavior Checklist (CBCL) were compared at the baseline, weeks 2 and 4, and end point. The side effects of aripiprazole, electrocardiogram (ECG), and body mass index (BMI) were evaluated., Results: Over the 8-week trial, aripiprazole administration was associated with a significant decrease in total tic severity as measured by the YGTSS (50.3% reduction by week 8). The mean scores of motor tic in the YGTSS were 17.42 +/- 4.83, 12.93 +/- 3.76, 8.39 +/- 3.70, and 6.75 +/- 3.95 at baseline, weeks 2 and 4, and end point. A significant decrease in the scores was observed in week 2 compared to the baseline, and the scores continued to decrease for the remainder of the study period (degrees of freedom [df ] = 3, F = 96.02, p = 0.000). The mean phonic tic scores were 12.71 +/- 4.60, 8.53 +/- 3.26, 6.10 +/- 2.50, and 3.63 +/- 2.20 at baseline, weeks 2 and 4, and end point, respectively. A significant change was observed during week 2 compared to the baseline, and this change continued for the rest of the study period (df = 3, F = 95.16, p = 0.000). Significant improvement was also observed according to the CGI-Tics severity. The mean CGI-Tics severity score was 4.77 +/- 1.69 at baseline and decreased to 2.20 +/- 1.39 at end point (t = 10.70, p = 0.000). A significant reduction of behavior symptoms was noticed according to the CBCL and its subscales between baseline and end point. The majority of subjects tolerated aripiprazole well. The extrapyramidal symptoms (EPS) during this study were negligible. In all 21 (29.2%) of the 72 participants complained of nausea and 19 (26.4%) of them reported sedation. There was no significant difference of BMI between the two phases (df = 64, t = -0.94, p = 0.352). There were no significant changes in laboratory results. ECG monitoring revealed no significant impact on cardiac conduction by aripiprazol., Conclusion: In this preliminary open-label trial, aripiprazole showed effectiveness in treating tic symptoms without causing significant weight gain or other serious side effects. Aripiprazole could be an option for TD cases that do not respond to conventional therapies. Further controlled, double-blind studies are warranted.

Objective: The aim of this study was to conduct a prospective safety and tolerability study of aripiprazole for the treatment of tics in children and adolescents with Tourette's disorder (TD)., Method: Eleven subjects (10 males) with TD (age 9-19 years, mean 13.36, standard deviation [SD] 3.33) who did not respond or were unable to tolerate previous tic medication were treated with aripiprazole in an open-label, flexible-dosing study over 10 weeks. Tic severity was rated using the Yale Global Tic Severity Scale (YGTSS) and the Clinical Global Impressions Scale for tics (CGI-Tics) at baseline and at follow-up., Results: The mean (+/-SD) daily dose for aripiprazole was 4.5 +/- 3.0 mg. Mean (+/-SD) YGTSS Global Severity scores reduced from 61.82 +/- 13.49 at baseline to 33.73 +/- 15.18 at end point; mean YGTSS total tic scores reduced from 28.18 +/- 7.74 at baseline to 16.73 +/- 7.54 at end point. Mean (+/-SD) CGI-Tic severity scores reduced from 4.45 +/- 0.52 (moderate-marked) at baseline to 3.18 +/- 0.60 (mild) at end point. On the CGI-Tic improvement scale, 10 (91%) subjects achieved 1 ("very much improved") or 2 ("much improved") at end point. Most common adverse effects included appetite increase and weight gain in 5 subjects, mild extrapyramidal effects in 7 subjects, and headaches and tiredness/fatigue in 7 subjects; 1 subject experienced akathisia and muscle cramps., Conclusion: Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics; it should be further investigated as a treatment option in controlled trials.

Objectives: This study evaluated flexible-dose pharmacokinetics, safety, and effectiveness of aripiprazole in children and adolescents with conduct disorder (CD)., Methods: This open-label, 15-day, three-center study with an optional 36-month extension enrolled a total of 23 patients: 12 children (6-12 years) and 11 adolescents (13-17 years) with CD and a score of 2-3 on the Rating of Aggression Against People and/or Property (RAAPP). Initially, the protocol used the following dosing: subjects <25 kg, 2 mg/day; subjects 25-50 kg, 5 mg/day; subjects >50-70 kg, 10 mg/day; and subjects >70 kg, 15 mg/day. Due to vomiting and sedation, this schedule was revised to: <25 kg, 1 mg/day; 25-50 kg, 2 mg/day; >50-70 kg, 5 mg/day; and >70 kg, 10 mg/day., Results: Aripiprazole pharmacokinetics were linear, and steady state appeared to be attained within 14 days. Both groups demonstrated improvements in RAAPP scores and Clinical Global Impressions-Severity (CGI-S) scores. Adverse events were similar to the known profile for aripiprazole in adults., Conclusion: The pharmacokinetics of aripiprazole in children and adolescents are linear and comparable with those in adults. Aripiprazole was generally well-tolerated in patients with CD, particularly after protocol adjustments, with improvements in aggressive behavior.

Objective: The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder., Method: This is a 14-week, prospective, open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I)., Results: Twenty-five subjects, ages 5-17 years (mean 8.6 years) received a mean final aripiprazole dosage of 7.8 mg/day (range 2.5-15 mg/day). Full-scale intelligence quotient (IQ) scores ranged from 48 to 122 (mean 84). Twenty-two (88%) of 25 subjects were responders in regard to interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-I of 1 or 2 (very much or much improved) and a 25% or greater improvement on the ABC-I. The final mean CGI-I was 1.6 (p

Objective: We conducted a retrospective, observational study of aripiprazole for the treatment of tics and/or co-morbid explosive outbursts in 37 children and adolescents with Tourette disorder (TD)., Method: Thirty seven children and adolescents with TD, with and without explosive outbursts, and refractory to previous treatment were treated at one of two university affiliated specialty clinics. All diagnoses were made using Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria. Tic severity was rated using the Clinical Global Impressions Scale for tics (CGI-Tics) and frequency of explosive outbursts was assessed using the CGI-Rage; both measures were obtained at pretreatment baseline and at posttreatment follow up., Results: High rates of psychiatric co-morbidity were observed in these subjects: 31 of 37 (84%) subjects met criteria for obsessive-compulsive disorder (OCD), and 31 of 37 (84%) met criteria for attention-deficit/hyperactivity disorder (ADHD). Twenty nine of 37 (78%) subjects met criteria for intermittent explosive disorder (IED) minus criterion C; the remaining 8 subjects had TD only. Eight subjects (22%) discontinued treatment before 12 weeks due to inability to tolerate the drug. At follow up, tics reduced at a mean daily dose of 12.3 (7.50) mg in 29 of 29 (100%) subjects who completed the study, and explosive outbursts improved in 24/25 subjects (96%) who completed the study. Aripiprazole was tolerated reasonably well, although 8/37 (22%) subjects discontinued treatment; most common side effects included weight gain, akathisia, and sedation., Conclusion: Aripiprazole should be investigated further as a treatment option for TD with and without co-morbid explosive outbursts.

Objective: To examine the effectiveness and cognitive effects of aripiprazole (APZ) in children with a primary diagnosis of attention-deficit/hyperactivity disorder (ADHD)., Methods: Youths, ages 8-12 years, with a diagnosis of ADHD combined-type or ADHD predominately inattentive-type were enrolled into a 6-week, open-label pilot trial. Outcome measures included the ADHD Rating Scale-IV (ARS-IV), Clinical Global Impressions Scale (CGI), and Children's Global Assessment Scale (CGAS). The Conners' Continuous Performance Test II, Reading and Math Fluency subscales of the Woodcock-Johnson III Tests of Achievement, and the Stroop Color and Word Test were administered at baseline and end of study., Results: Fourteen (9 males and 5 females) youths were diagnosed with ADHD-combined type, while 9 (5 males and 4 females) were diagnosed with ADHD-inattentive type. At a mean dose of 6.7 mg/day, end of study results showed overall significant improvement from baseline on ADHD and functional outcome measures. No significant differences in baseline performance at end of study were found on the cognitive measures. The most frequently reported adverse events were sedation (n = 18; 78.3%) and headache (n = 11; 47.8%)., Conclusions: Although this was a brief pilot study with a small sample size, in this cohort, APZ led to clinical benefit in reducing ADHD symptoms and improving overall functioning. Of note, cognitive functioning did not appear to be negatively impacted by APZ treatment.

Objective: This study was conducted to evaluate the effectiveness of aripiprazole to reduce the severity and frequency of tic symptoms and to evaluate the additional effects of aripiprazole on weight changes in children and adolescents with Tourette disorder (TD) or chronic tic disorders., Methods: A 12-week, open-label trial with flexible dosing strategy of aripiprazole was performed with 15 participants, aged 7-19 years. The Yale Global Tic Severity Scale was applied and the baseline, week 3, 5, 9, and end point scores were compared. The mean body mass index (BMI) at baseline and end point were also compared., Results: Significant decreases in the scores of motor and phonic tics, global impairment, and global severity were demonstrated between baseline and week 3, and the scores continued to improve thereafter. No difference was observed between the baseline and end point BMI., Conclusion: This study demonstrates that a relatively low dose of aripiprazole can be used to control tic symptoms effectively in children and adolescents with TD and chronic tic disorders without causing significant weight gain. Additional double-blind studies are needed to establish the definitive efficacy of aripiprazole in treating children and adolescents with chronic tic symptoms.

Objective: The aim of this study was to report on the clinical efficacy and side effects of aripiprazole in treating behavioral symptoms of children with a developmental disability (DDs)., Design/methods: A retrospective chart review of the first 32 children treated with aripiprazole at an urban clinic for children with DD was conducted., Results: Ages ranged from 5 to 19 years; 9 (28%) were female. Twenty four had diagnoses within the autistic spectrum and 18 had mental retardation (MR). Other disorders included: attention-deficit/hyperactivity disorder/disruptive behavior disorders (n = 13), mood disorders (n = 7), reactive attachment (n = 2), and sleep disorders (n = 2). Target symptoms included aggression, hyperactivity, impulsivity and, self-injurious behaviors. Twenty eight of the children were switched from another antipsychotic. The mean daily aripiprazole starting dose was 7.1 +/- 0.32 mg (0.17 mg/kg/day) and the mean daily maintenance dose was 10.55 +/- 6.9 mg (0.27 mg/kg/day). Aripiprazole had been used for a period between 6 and 15 months. Improvement in target symptoms was found in 56%. When treating a child with MR, the concomitant presence of an autistic spectrum diagnosis predicted a worse outcome. Side effects were reported in 16 (50%), with the most frequent being sleepiness (n = 6). Mean body mass index (BMI) rose from 22.5 to 24.1 (p = 0.003) over the follow up period, with changes in the BMI z scores. These changes were more pronounced in children younger than 12 years., Conclusions: These results with aripiprazole in this difficult-to-treat population suggest that this medication warrants controlled studies of its effectiveness and safety.