The Yale Child Study Center is recruiting participants for a study and asked me to post this notice. The study has been approved by Yale’s Institutional Review Board:
I am writing to inform you of a pilot study at the Yale Child Study Center. The purpose of this study is to investigate the efficacy and dosing of a new extended-release form of guanfacine (trade name Intuniv®) for the treatment of tics in children with a Chronic Tic Disorder.
This study, funded by Shire Pharmaceuticals, is being conducted Yale and at two other research centers, New York University Child Study Center and University of Southern Florida. Guanfacine, which is primarily used to treat high blood pressure, has also been used to treat children with Tourette Syndrome (TS) and Attention Deficit Hyperactivity Disorder (ADHD). Although this drug has been used in TS with some success, the direct effect of the medication on tic severity has not been formally studied. In 2009, a new extended-release form of guanfacine was approved by the FDA for treatment. This pilot study will examine the efficacy and dosage of this new extended-release formula in hopes of finding a new medication to treat tics with limited adverse effects.
Eligible children are between the ages of 6 and 17, weigh at least 15 kg (33 lbs), and have a DSM-IV diagnosis of Tourette Disorder or a Chronic Tic Disorder (Chronic Motor Tic or Chronic Vocal Tic). Once enrolled, children will be randomly assigned to either the active treatment or placebo. Regardless of assignment, children will be placed in an 8 week treatment program of an increasing dosage with follow-up visits at 2 week intervals. Medication will be carefully monitored throughout the entire program. If necessary, the medication dose will be lowered or ceased.
After the 8 week treatment period, children will be assessed for treatment response. Children who were assigned to the active treatment and had a decrease in tic severity will be allowed to continue treatment for another 8 weeks. Children in the placebo control group who did not show any improvement will be given the option to try guanfacine for an 8 week period. During this extension phase, participants will be required to attend 2-4 additional follow-up visits.
With your help, we can complete this pilot study and contribute to the advancement of effective treatments for Chronic Tic Disorders. Enclosed is a brief information sheet describing the study. These flyers are not intended for general distribution to parents, but can be posted on bulletin boards or in common areas. Parents who express interest can be given a flyer.
If you have any questions or would like to discuss specific cases and referrals, please feel free to contact us at any time. Thank you for your attention.
Lawrence Scahill, MSN, PhD, Principal Investigator
You can download the flyer on the study here. If you’d like to participate or have questions, contact:
Clinical Research Coordinator
Tel: (203) 737-5317
Amy Norton of Reuters reports:
Some parents swear by fish oil as a treatment for the “tics” caused by Tourette’s disorder, but so far the research evidence is slim.
In a small study of children with Tourette’s, researchers found that omega-3 fatty acids were no better than a placebo at reducing the severity of tics — the sudden, involuntary movements or vocalizations that mark Tourette’s.
On the other hand, children who took omega-3 did show an improvement in the degree to which their tics bothered them, researchers report in the journal Pediatrics.
A Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acids in Tourette’s Disorder
Vilma Gabbay, James S. Babb, Rachel G. Klein, Aviva M. Panzer, Yisrael Katz, Carmen M. Alonso, Eva Petkova, Jing Wang, and Barbara J. Coffey
Pediatrics peds.2011-3384; published ahead of print May 14, 2012, doi:10.1542/peds.2011-3384
A review article on the use of antipsychotics in the treatment of tics was published in March and is available online. For parents who are new to the treatment of tics, let me hasten to explain that although neuroleptics are referred to as “antipsychotics,” their use is not restricted to those who have psychotic disorders or symptoms. Back in the 1960′s, clinicians discovered that in small doses, “antipsychotics” might help ameliorate tics. They do not cure tics, but they may reduce their frequency or severity.
Here is the abstract of the article:
Tourette syndrome (TS) is a neuropsychiatric disorder with typical onset in childhood and characterized by chronic occurrence of motor and vocal tics. The disorder can lead to serious impairments of both quality of life and psychosocial functioning, particularly for those individuals displaying complex tics. In such patients, drug treatment is recommended. The pathophysiology of TS is thought to involve a dysfunction of basal ganglia-related circuits and hyperactive dopaminergic innervations. Congruently, dopamine receptor antagonism of neuroleptics appears to be the most efficacious approach for pharmacological intervention. To assess the efficacy of the different neuroleptics available, a systematic, keyword-related search in PubMed (National Library of Medicine, Washington, DC) was undertaken. Much information on the use of antipsychotics in the treatment of TS is based on older data. Our objective was to give an update and therefore we focused on papers published in the last decade (between 2001 and 2011). Accordingly, the present review aims to summarize the current and evidence-based knowledge on the risk-benefit ratio of both first and second generation neuroleptics in TS.
Neuropsychiatr Dis Treat. 2012;8:95-104. Epub 2012 Mar 12.
Update on the role of antipsychotics in the treatment of Tourette syndrome.
Huys D, Hardenacke K, Poppe P, Bartsch C, Baskin B, Kuhn J.
You can access the free full-text article on PubMed Central. Note that not all of the medications are approved for use in the U.S.; some are only available in Europe. The medication names are also the generic names, not the trade names by which you may know them. So here is a conversion guide based on U.S. trade names:
|Generic Name||Trade Name (U.S.)|
|Benzamides: tiapride, sulpiride, and amisulpride||(not marketed in U.S.)|
Keep in mind that these are not the only medication alternatives in treating tics. Indeed, many physicians do not even start with the neuroleptics (antipsychotics) but start with other types of medications that may also reduce tics. And of course, medication is not the only available treatment for tics. Research supports the use of CBIT (formerly known as “Habit Reversal”) in the treatment of tics.
Back in November, I noted that there was a bizarre outbreak of Tourette-like symptoms in a number of high school girls in LeRoy, New York. Since that time, the number of people affected has increased, and controversy has continued to swirl around that cause of the outbreak. While some have argued that the cases are due to conversion disorder (“mass hysteria”), others have sought a more organic basis. Erin Brockovich has been conducting her own investigation into the possibility that environmental contaminants are responsible. As of today, there is no evidence that environmental contaminants are the likely cause, but investigations are not complete. Others have claimed that PANDAS (now called PANS) is the cause (i.e., an autoimmune response to infection gone awry). An article by Alison Motuk in Nature provides some of the background on this case and the possibilities that are being explored. The following segment and other news clips linked at the end of the segment give a sense of how complicated this situation has been:
A number of minor changes and one big change have been proposed for tic disorders. One of the changes made for all tic disorders has been to redefine a tic as “a sudden, rapid, recurrent, nonrhythmic motor movement or vocalization.” The work group also removed the term “stereotyped” from the definition of a tic and proposes removing the phrase ” usually in bouts” from the diagnostic criteria for Tourette’s, where they also propose deleting the criterion of a tic-free period of no more than 3 months.
To see how existing tic disorders are changing in their diagnostic criteria, follow the links below. You will see the proposed diagnostic criteria. By clicking on the “rationale” tab, you will find the work group’s explanation for the proposed criteria. Clicking on the “DSM-IV” tab will show you the existing diagnostic criteria:
- 307.23 Tourette’s Disorder
- 307.22 Chronic Motor or Vocal Tic Disorder
- 307.21 Transient Tic Disorder
- 307.20 Tic Disorder Not Otherwise Specified
Two new tic-related diagnoses have also been proposed:
The biggest proposed change, however, has nothing to do with specific diagnostic criteria for tic disorders, but has to do with how and where tic disorders are grouped in the DSM-V classification of disorders. If the existing Childhood Disorders category remains in the DSM-V, tic disorders will remain under that grouping, but if that grouping is eliminated, the work group recommends listing tic disorders under a new grouping to be called “Anxiety and Obsessive-Compulsive Disorders.”
I think that this is a terrible idea, and I’ve outlined my concerns in feedback I submitted to the workgroup and in a letter to the editor I wrote that was published in Psychiatric Times, “DSM5 Proposal Triggers Anxiety, Not Tics.”