Risperidone Monotherapy in Children and Adolescents with Autism Spectrum Disorders: A Naturalistic Study

OBJECTIVES: We retrospectively investigated the efficacy and tolerability of risperidone monotherapy in subjects with autism spectrum disorder (ASD). In addition, we did mixed effect model analysis of the effects of risperidone in patients with ASDs naturalistically treated in a routine clinical setting to determine whether the clinical effects were maintained and the side effects were tolerable. METHODS: This retrospective study assessed children and adolescents with ASD, who were on risperidone monotherapy from July 2010 to July 2011 at the Child and Adolescent ASD Clinic at Seoul National Hospital. Outcome measures included the Clinical Global Impression-Severity of Illness (CGI-S) and the CGI-Improvement (CGI-I) scales along with other clinical indices: dosage, target symptoms, and side effects. RESULTS: The mean dose of risperidone in 47 children and adolescents with ASD (40 males, 7 females; age range 5-19 years) who were on risperidone monotherapy was 1.6+/-0.8 mg/day, and the mean duration of the treatment period was 20.2+/-17.3 months. Aggressive behavior, stereotypic behavior, irritability, and self-injurious behavior were the most frequent target symptoms of risperidone. The most common side effects were weight gain followed by somnolence and extrapyramidal symptoms. In a mixed effects model analysis of CGI-I scores, the mean CGI-I score at the 1 month follow-up was significantly different from the mean CGI-I score of the 3-month follow-up (p=.046), and the CGI-I scores were equally maintained over 3 to 48 months [F(6, 28.9)=4.393, p=.003]. Of the 47 patients, 33 patients (70.2%) were identified as the response group, showing an end point CGI-I rating of 3 or under and having continued risperidone treatment for at least 6 months. The baseline CGI-S score showed significant association with clinical response to risperidone (p=.005), the mean baseline CGI-S was higher in the response group compared to the non-response group. CONCLUSION: In this study, clinical improvement of risperidone stabilized around 3 months and was equally maintained up to 48 months with tolerable side effects, supporting maintenance of risperidone treatment in children and adolescents with ASDs.

Clinical Characteristics of Methylphenidate Use in Korean Children and Adolescents with Autism Spectrum Disorder : A Retrospective Study

OBJECTIVES: The purpose of this study was to investigate clinical characteristics of children and adolescents with autism spectrum disorders (ASDs) using methylphenidate (MPH). METHODS: Retrospective review of the charts of 79 children and adolescents with ASDs, who visited the Department of Child and Adolescent Psychiatry of Seoul National Hospital, from July 2010 to July 2011, was conducted. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity of illness (CGI-S) and Clinical Global Impression-Improvement (CGI-I) Scales. RESULTS: We found that MPH was prescribed in 23 (29.1%) children and adolescents. Of the 23 patients on MPH, 4 patients (17.4%) were on MPH monotherapy and 18 patients (78.3%) were using risperidone concomitantly. MPH was prescribed primarily for symptoms of hyperactivity and impulsivity in ASDs patients. The mean dosage of MPH was 26.2+/-11.1mg/day and mean duration of treatment was 31.9+/-28.7 months. Mean CGI-S score improved significantly from baseline to endpoint (from 5.4+/-0.6 to 4.1+/-0.9 ; p<.01). MPH was reported to be effective in 17 patients (17/23, 73.9%), and 10 patients (10/23, 43.5%) reported side effects. Side effects included decreased appetite (4/23, 17.4%), tic (2/23, 8.6%), sleep disturbances (2/23, 8.6%), headache (1/23, 4.3%) and irritability (1/23, 4.3%). CONCLUSION: The results of this study demonstrate that MPH may be used effectively and safely in children and adolescents with ASDs with hyperactivity and impulsivity. Future controlled trials are needed to confirm these findings.

Retrospective Analyses of Long-Term Use of SSRI in Children and Adolescents with Autism Spectrum Disorder

OBJECTIVES: The purpose of this study was to investigate clinical profile, efficacy, and safety of long-term treatment with selective serotonin reuptake inhibitors (SSRIs) in Korean autism spectrum disorders (ASDs) patients. METHODS: Effectiveness was assessed through a retrospective review of self-reported target symptom improvement at the last follow-up visit. Changes in illness severity and improvement were measured using the Clinical Global Impression-Severity (CGI-S) of illness and Clinical Global Impression-Improvement (CGI-I) Scales. Tolerability was assessed through a review of the reason for discontinuation of SSRI and documented adverse events. RESULTS: A total of 21 ASDs patients (aged 9 to 19 years) treated with SSRI during July 2010 to July 2011 in department of child and adolescent psychiatry of Seoul National Hospital were identified. The mean duration of SSRI treatment was 47.9 (standard deviation = 36.9) months (range 0.7-114.5), and the mean fluoxetine equivalent dosage of SSRIs was 27.1 +/- 10.8 mg. Nineteen (90.5%) patients were using concomitant medication. We found that SSRIs were prescribed for symptoms of agitation, stereotyped behavior, aggression, depression, impulsivity and self-injury in ASDs. Ten patients (47.6%) reported improvement in their target symptom after SSRI treatment based on CGI-I scores (CGI-I < or = 2). The side effects were reported in 5 patients (23.8%) ; vomiting (n = 2, 9.5%), excessive mood elevation (n = 1, 4.8%), insomnia (n = 1, 4.8%), somnolence (n = 1, 4.8%) and decreased appetite (n = 1, 4.8%). Self-injurious behavior was reported in one patient (4.8%). CONCLUSIONS: The results of this study suggest that SSRIs may be used effectively in children and adolescents diagnosed with ASDs. However, safety issues need to be considered carefully when choosing SSRIs for treatment. Future controlled trials are needed to confirm these findings.