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Olanzapine in the treatment of behavioral problems associated with autism: an open-label trial in Kuwait
Abdullahi Fido1, Samira Al-Saad
1Department of Psychiatry, Faculty of Medicine, Health Sciences Centre, Kuwait University, Kuwait. fido@hsc.edu.kw
Insights
Olanzapine effectively reduced disruptive behaviors like irritability and hyperactivity in children with autism. This short-term study found the medication safe, but longer trials are needed to assess side effects.
Area of Science:
- Child and Adolescent Psychiatry
- Neurodevelopmental Disorders
- Pharmacological Interventions
Background:
- Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition.
- Disruptive behaviors, including irritability and hyperactivity, are common in children with ASD.
- Effective and safe pharmacological interventions for these behaviors are needed.
Purpose of the Study:
- To evaluate the efficacy and safety of olanzapine in treating disruptive behavior problems in children with autism.
- To assess the impact of olanzapine on specific behavioral symptoms and overall severity.
Main Methods:
- A 13-week prospective open-label trial involving 40 male children (ages 7-17) diagnosed with autism.
- Olanzapine (5-10 mg/day) was administered after a washout period.
- Efficacy was measured using the Aberrant Behavior Checklist (ABC) and Clinical Global Impressions-Severity (CGI-S).
- Laboratory and physical investigations were conducted at baseline and end of treatment.
Main Results:
- Significant reductions were observed in ABC subscale scores for irritability, lethargy, stereotyped behavior, hyperactivity, and inappropriate speech (p < 0.005).
- 30% of patients showed improvement on CGI-S scores (p < 0.05).
- No significant adverse effects on liver enzymes, serum biochemistry, or body weight were noted.
Conclusions:
- Olanzapine demonstrated potential benefits in alleviating irritability, hyperactivity, and lethargy associated with autism in children.
- The short duration of the trial limits conclusions regarding long-term adverse effects like weight gain and tardive dyskinesia.
- Further long-term, placebo-controlled studies are recommended to confirm efficacy and safety.
Objectives:
To study the efficacy and safety of olanzapine for the treatment of children with autism associated with disruptive behavior problems.
Subjects And Methods:
A prospective open-label trial was conducted on 40 male children (mean age 12.2 +/- 2.2 years, range 7-17 years) meeting Diagnostic Statistical Manual IV criteria for autism. After a washout period from previous medications (2-14 days), patients received olanzapine (5-10 mg/day) for a 13-week treatment period. The primary efficacy measures were Aberrant Behavior Checklist (ABC) and Clinical Global Impressions-Severity (CGI-S) done at baseline and end of treatment. At the beginning and end of treatment, patients underwent laboratory and physical investigations: ECG, chest X-ray, urinalysis, serum chemistry, blood glucose and lipid profile, hematology and hepatitis B serology.
Results:
Paired comparison of baseline and 13-week endpoint scores showed significant reductions in ABC subscale scores for irritability (p < 0.0001), lethargy (p < 0.0001), stereotyped behavior (p < 0.005), hyperactivity (p < 0.0001) and inappropriate speech (p < 0.005). Of 40 patients, 12 (30%) were considered as 'improved' on CGI-S scores compared to baseline, a statistically significant difference (p < 0.05). No liver enzyme elevation or any other serum biochemical changes resulted from treatment, which was not associated with significant body weight changes or any other treatment-emergent side effects.
Conclusions:
The study shows that olanzapine treatment can be beneficial in alleviating some behavioral symptoms (irritability, hyperactivity/noncompliance and lethargy/withdrawal) associated with autism. The short period of this trial limits inferences about adverse effects such as body weight increase and tardive dyskinesia. Further long-term placebo-controlled studies of olanzapine are required.
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