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SIGN Guideline 98: Assessment, diagnosis and clinical interventions for children and young people with autism spectrum disorders
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Any pharmacological treatment considered for children and young people with ASD should not be viewed in isolation but seen as a possible component of a multistranded package of care.
There are no controlled long term studies demonstrating that pharmacological interventions affect the core difficulties or outcomes in children and young people with ASD. There is no evidence directly comparing pharmacological and non-pharmacological approaches.
Pharmacological treatment may be considered when appropriate, for treatment of comorbid psychiatric or neurodevelopmental conditions in ASD. Pharmacological treatment may also be considered as a short to medium term intervention for specific severe symptoms occurring in children and young people with ASD. Treatment for other comorbid medical conditions, eg epilepsy, which may be required for children and young people with ASD, is not further discussed in this guideline (see SIGN guideline 81 diagnosis and management of epilepsies in children and young people).155
Only medications available in the UK are discussed. No pharmacological treatments have ASD as a licensing indication, and there are few drugs specifically licensed for use in children and adolescents.
An assessment of the need for pharmacological intervention should include an appraisal of the child’s environment (school and home) and daily routines (eg sleep, daily activities, meals etc). Changes in these areas may be worth attempting before using medication, and are likely to complement the effects of medication, if it is appropriate for this to be prescribed. It is possible that treatment of comorbid difficulties with medication may enhance the ability of children and young people to benefit from other approaches. There have as yet been no systematic studies of combining other interventions and medication.
The potential balance of risks and benefits from any pharmacological treatment needs to be considered for each individual child, and discussed as appropriate with them and their parents/carers, so that they can make an informed decision.
If a trial of pharmacological treatment is agreed, there should be careful pre-treatment assessment of the child’s overall symptoms and functioning, and definition of the ‘target symptoms’, ie those expected to respond to the drug, as far as possible. There should be agreement about how symptoms and any emergent side effects of treatment will be measured, as well as the monitoring arrangements and expected duration of any trial of medication. Children and young people, their parents/carers and clinicians, should, as far as possible, plan how they intend to make a decision about whether or not to continue with medication, after any trial period.
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Pharmacological treatment of children with ASD should only be undertaken by doctors with appropriate training and access to pharmacy or other support as required.
Risperidone in low doses (up to 2 mg daily in children weighing up to 45 kg and up to 3.5 mg daily in those weighing over 45kg)156 may be helpful in reducing severe irritability and aggression in children or young people who have autistic disorder and significant aggression, tantrums or self injury. Effects persisted at six months, but not after medication was discontinued.157 Scores on repetitive/stereotyped behaviours were reduced but there was no effect on core social deficits.158 Similar findings were reported in a separate though less robust trial.159 In both these trials the majority of patients had learning disability. Adverse effects (most commonly tiredness/sedation early in treatment and increased appetite and weight gain) occurred more often with risperidone.159, 160 A small blinded discontinuation trial in a group with ASD where two thirds were of normal intellectual ability indicated a possible effect of risperidone on severe aggression, tantrums and self injurious behaviour.161 Evidence level 1+
Weight gain may be a significant problem at daily doses of 2 mg and lower.156, 162, 163 There is no evidence that any specific variables predict weight gain.164 Evidence level 1+
Liver function tests do not appear to be significantly affected by up to 12 months treatment with risperidone.163-165 Evidence level 1+
In young children (under 10 years) with ASD, raised prolactin levels without obvious clinical effects, have been associated with short term (three months) risperidone treatment.166-168 Levels fell by 24 weeks in the only study where measurement was repeated.166 No data are available for older children or adolescents. The implications of raised prolactin levels are unknown. Evidence level 1+
B - Risperidone is useful for short term treatment of significant aggression, tantrums or self injury in children with autism
- Weight should be monitored regularly in children and young people who are taking risperidone.
Doctors should inform young people and parents that prolactin levels may rise in association with risperidone treatment and that the implications of this are unknown.
There is evidence that methylphenidate reduces hyperactivity in children up to 14 years with ASD and comorbid ADHD (with a mean IQ in the learning disability range).160 This finding is supported by clinical experience/expert opinion about the use of stimulant medication in children with ASD and attentional/hyperactivity problems (see SIGN guideline 52 on attention deficit and hyperkinetic disorders in children and young people).171 Adverse effects (difficulty falling asleep, appetite decrease, irritability and emotional outbursts) were more common in children receiving methylphenidate compared to those on placebo.160 In one study from a specialist paediatric clinic, response to methylphenidate and level of side effects were not significantly different in children with ADHD and ASD compared with children with ADHD alone.169 The use of a test dose is worthwhile to assess whether methylphenidate will be tolerated.160, 170 Evidence level 1+, 4
There is no evidence about the use of other stimulant medication for these problems in children and young people with ASD. If methylphenidate is not tolerated use of other medication could be considered with reference to SIGN guideline 52 on attention deficit and hyperkinetic disorders in children and young people.171
B Methylphenidate may be considered for treatment of attention difficulties/hyperactivity in children or young people with ASD.
- Use of a test dose to assess if methylphenidate is tolerated could be considered in children prior to any longer trial.
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Side effects should be carefully monitored (see SIGN guideline 52 on attention deficit and hyperkinetic disorders in children and young people).171
A single RCT indicated statistically significant but small clinical benefit from fluoxetine on repetitive behaviours in children and young people with ASD. Side effects were similar to placebo.172 Evidence level 1+
A case series of young children with ASD treated with fluoxetine found parent reported response correlated with associated features including parent reported family history of affective disorder.173 Evidence level 3
There is insufficient evidence to make a recommendation about the use of fluoxetine.
All studies related to children less than eight years of age and naltrexone did not improve symptoms of ASD.174-177 Evidence level 1+
Secretin (human or porcine) as a single dose, or in multiple doses, for up to six months does not improve ASD symptoms, and no subgroup of children who benefit has been consistently identified.178-187 Evidence level 1++
A Secretin is not recommended for use in children and young people with ASD.
Melatonin is not licensed as a medication in the UK, although it is in clinical use to treat sleep problems in children and young people with ASD or other developmental difficulties.
In typically developing children there is some evidence that melatonin improves sleep difficulties which have persisted after behavioural treatment.188-190 Evidence level 3
For developmentally disabled children (only a very few of whom had ASD), there is evidence that melatonin is tolerated but it is not clear if it is of any benefit.191, 192 Evidence level 3
One small RCT including limited diagnostic and clinical information suggested that melatonin improves sleep in children with autism.193 Evidence level 1+
An uncontrolled study indicated melatonin was tolerated in children and young people with Asperger’s syndrome.194 Evidence level 3
D Melatonin may be considered for treatment of sleep problems which have persisted despite behavioural interventions.
Obtain an adequate baseline sleep diary before any trial of melatonin.
There is insufficient good quality evidence to make recommendations on the use of the following drugs, amantadine, (a single small RCT indicated possible benefit on investigator, but not parent rated, measure of hyperactivity195), cyproheptadine as an adjunct to haloperidol (high risk of side effects)196 or divalproex sodium.197, 198
For the following drugs single RCT evidence does not indicate benefit: clomipramine (high rate of side effects),199 lamotrigine (in children under 11),200 vancomycin (outcome measured two to eight months after course of treatment in children with regressive autism).201
Observational studies only have been completed for aripiprazole, citalopram, fluvoxamine, guanfacine, olanzapine, quetiapine, sertraline or venlafaxine.
Sertraline is licensed for treatment of obsessive compulsive disorder (OCD) in children and adolescents, and its use may be relevant in children or young people with ASD who have comorbid OCD. The diagnosis may be difficult as compulsive behaviours are common in ASD. Some children do have evidence of more typical OCD features with repetitive thoughts or behaviours which appear to them as senseless and are, at least to some extent, resisted. The possibility of benefit at a low dose of sertraline and worsening at a higher dose was indicated in a single very small descriptive study of anxiety symptoms in children with ASD.202
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Last modified
10/05/10
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