Despite their widespread use amongst doctors who treat adults with developmental disabilities and mental retardation, a new study has found that a specific type of psychiatric medication — antipsychotics — to be ineffective in helping reduce these individuals’ aggressive behavior. Antipsychotics are generally not FDA-approved for the treatment of aggressive behavior, this has simply been an off-label and common practice by many physicians for years.
The researchers followed 86 non-psychotic people with an intellectual disability (what we in the U.S. would term either a developmental disability or mental retardation) and aggressive or challenging behaviors. Patients were randomly assigned to one of three treatment groups — an older antipsychotic (Haldol), a newer atypical antipsychotic (Risperdal), or placebo (a sugar pill).
Professionals assessed patients for aggression, aberrant behaviour, quality of life, adverse drug effects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs at 4, 12 and 26 weeks.
Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change — there were no significant statistical or clinical differences between these three groups. Why no difference? The researchers hypothesized in The New York Times coverage of the story:
“Being in the study, with all the extra attention it brought, was itself what apparently made the difference, he [a study author] said.
“‘These people tend to get so little company normally,’ Dr. Tyrer said. ‘They’re neglected, they tend to be pushed into the background, and this extra attention has a much bigger effect on them that it would on a person of more normal intelligence level.'”
These types of antipsychotic medications should never have been prescribed to these individuals for this concern (aggressive behavior) in the first place. So it’s not surprising to me that the researchers found them to be ineffective in the treatment of aggressive behavior.
Naturally, this is a possible wake-up call for the industry. When sugar pills are shown to be just as effective as a high-cost psychiatric drug, what will the next set of researchers find when they examine other common off-label uses of these medications?
The study was published in the January 5 issue of the UK journal, The Lancet.
Hat tip and further commentary: Furious Seasons
Link to article: New York Times
Link to research: Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial