Autism & Developmental

Lamotrigine therapy for autistic disorder: a randomized, double-blind, placebo-controlled trial.

Belsito et al. (2001) · Journal of autism and developmental disorders 2001
★ The Verdict

Lamotrigine is no better than a sugar pill for core autism traits.

✓ Read this if BCBAs whose families ask about new pills for autism.
✗ Skip if Clinicians already focused on behavioral plans.

01Research in Context

01

What this study did

Doctors gave kids with autism either lamotrigine or a sugar pill for 12 weeks. Nobody knew who got what.

They wanted to see if the drug would help core autism traits like talking, playing, or getting upset.

02

What they found

The drug group looked the same as the placebo group on every test.

Lamotrigine did not help language, play, or daily living skills.

03

How this fits with other research

Jepson et al. (2011) tried hyperbaric oxygen in kids with autism and also saw zero benefit. Two different pills, same null result.

Capio et al. (2013) tested risperidone in a similar RCT and found big drops in irritability. One autism drug works, one does not.

Laugeson et al. (2014) gave arbaclofen without a blind and parents saw gains. The open-label design may have hyped hope; the blinded lamotrigine trial shows why we need controls.

04

Why it matters

You can stop hunting for magic pills that fix autism. When parents ask about lamotrigine, show them this data and save them time, money, and side effects. Put your hours into ABA instead.

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→ Action — try this Monday

Tell the next parent who mentions lamotrigine: ‘Twelve weeks, double-blind, zero gain—let’s work on teaching skills instead.’

02At a glance

Intervention
not applicable
Design
randomized controlled trial
Sample size
28
Population
autism spectrum disorder
Finding
null

03Original abstract

In autism, glutamate may be increased or its receptors up-regulated as part of an excitotoxic process that damages neural networks and subsequently contributes to behavioral and cognitive deficits seen in the disorder. This was a double-blind, placebo-controlled, parallel group study of lamotrigine, an agent that modulates glutamate release. Twenty-eight children (27 boys) ages 3 to 11 years (M = 5.8) with a primary diagnosis of autistic disorder received either placebo or lamotrigine twice daily. In children on lamotrigine, the drug was titrated upward over 8 weeks to reach a mean maintenance dose of 5.0 mg/kg per day. This dose was then maintained for 4 weeks. Following maintenance evaluations, the drug was tapered down over 2 weeks. The trial ended with a 4-week drug-free period. Outcome measures included improvements in severity and behavioral features of autistic disorder (stereotypies, lethargy, irritability, hyperactivity, emotional reciprocity, sharing pleasures) and improvements in language and communication, socialization, and daily living skills noted after 12 weeks (the end of a 4-week maintenance phase). We did not find any significant differences in improvements between lamotrigine or placebo groups on the Autism Behavior Checklist, the Aberrant Behavior Checklist, the Vineland Adaptive Behavior scales, the PL-ADOS, or the CARS. Parent rating scales showed marked improvements, presumably due to expectations of benefits.

Journal of autism and developmental disorders, 2001 · doi:10.1023/a:1010799115457