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By Herb Newborg

Drug Widely Prescribed for Autism Deemed Worthless

SSRI drugs (selective serotonin reuptake inhibitors) account for 59% of the global market share of autism therapeutics -- estimated at $2.2 to $3.5 billion overall. But a new study calls into question their effectiveness for the treatment of the repetitive behaviors for which they are commonly prescribed.

No medications are currently FDA approved for the "core symptoms" of autism spectrum disorders, but selective serotonin reuptake inhibitors (SSRIs) are widely prescribed “off label” for these patients, the researchers noted.

A new study performed by Bryan H. King, M.D., of the University of Washington, and colleagues reported in the June issue of Archives of Psychiatry found that despite this common off-label use, the antidepressant citalopram (Celexa) has no effect on repetitive behavior in young patients with autism spectrum disorders and caused some of them to have nightmares.

"There is a robust literature that supports the use of selective serotonin reuptake inhibitors for obsessive-compulsive disorder, so we assumed that we'd see a very positive response," Dr. King said.

Instead, he said, the results further illustrate that there is "a fairly significant placebo response rate in kids with autism who are treated with medication."

"It might be very sobering to recognize that treatments that we thought were very helpful like citalopram for repetitive behaviors in fact may not be," Dr. King said, "and at the very least we need to revisit what the risks and benefits of some of these treatments are."

To determine the safety and efficacy of Celexa for repetitive behavior in children with autism spectrum disorders, the researchers conducted a randomized controlled trial of 149 patients ages 5 to 17 at six U.S. centers.

Patients received either Celexa or placebo for 12 weeks. Participants had autism spectrum disorders, Asperger disorder, or pervasive developmental disorder not otherwise specified, and all illnesses were at least moderate.

The researchers found no significant difference in the rate of positive response between Celexa and placebo on the two most widely accepted measurement scales (Clinical Global Impressions Improvement subscale and Children's Yale-Brown Obsessive-Compulsive scale ) .

Celexa use was significantly more likely to be associated with adverse events, particularly increased energy level, impulsiveness, decreased concentration, hyperactivity, stereotype, diarrhea, insomnia, and dry skin or pruritus.  Among the children who took Celexa, 7 percent experienced nightmares.

The researchers said it was notable that the placebo response was very high, although their placebo response rate of 34.2% is "consistent with some other studies involving children with autism and reinforces the value of placebo control in pediatric psychopharmacologic research."

"Ours is not the first to demonstrate this placebo effect," Dr. King said. "It may help to explain how it is that there are so many treatments being offered up as potentially useful in kids with autism."

Evidence is lacking when it comes to treatment of children with autism with other therapies, he said. Using SSRIs to treat anxiety and mood disturbances, for example, has not been formally studied.

"Those studies need to be done and I think that the fact that we did not see a signal for citalopram in this case really increases the urgency with which we should approach doing those studies," Dr. King said.

In an accompanying editorial, Fred R. Volkmar, M.D., of Yale, said that "unfortunately, pharmacological intervention studies have often been hampered by small sample sizes and ambiguous results."

He said the study done by Dr. King and colleagues is "an important step that addresses this major gap in the literature."

"The medication does not appear to be useful for repetitive behaviors in children with autism and related conditions," Dr. Volkmar said. "We need more studies of this kind to advance research and guide clinical practice. Perhaps these data will change this practice of prescribing antidepressants for autism."

Studies of non-drug care options such as chiropractic care have demonstrated improvement of many of the associated symptoms of autism, although not specifically repetitive behavior.

One study carried out a series of chiropractic adjustments on 26 autistic children over a 9-month period. Many of the children were taken off Ritalin, bladder and bowel control improved, some children started to speak and eye contact and attention span also improved in some children. Hyperactivity and aggressive behavior were reduced in other children and five children were able to attend mainstream classes at school for the first time. Behavioral data, recorded by the teachers and parents, showed significant improvements in most cases.

The authors of the study believed that the children were suffering from nerve interference (subluxation) contributing to their diagnosis of autism. This nerve interference (subluxation) was thought to have hindered the development of the child, interfering with their ability to reach their full potential. The authors believed that correcting the subluxation improves local nerve function, allowing for more neurological integration, enabling an overall improvement in function.

Sources:
Archives of Psychiatry, (2009) (6)
Journal of Clinical Chiropractic Pediatrics (2000) (1)