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
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.
Regardless of whether your child takes medication only at home or takes medication in school, there are steps to take to protect their safety.
For Children Taking Medication Only at Home
If your child is changing schools this year, do you know for sure whether their medical records and notes you may have sent the school nurse about side effects or concerns have been forwarded to the new school? Although some school records do transfer, don’t assume that medication records transfer. Find out who in the district and/or building you should contact with information about your child’s current medications and then send in a note informing them what medication your child is on, what time they it is taken, and any side effects your child experiences.
Even if your child is not supposed to take medication in school, if you think you may occasionally forget to give your child their pre-school dose of medication, send in a supply in a labeled prescription bottle that has your child’s name on it with the name of the physician and dose. Include a prescription or letter from the physician that authorizes the school to administer the morning dose if you should call to say that your child missed the morning dose.
Some parents prefer not to tell the school about any medications the child takes only at home. That is an individual decision and I understand both sides of the issue, but let me remind parents that if anything ever happens at school and your child is transported to an Emergency Room or is unconscious and cannot communicate, someone in the school or district should know what medication(s) your child has ingested so that emergency medical personnel can be informed.
For Children Who Take Medication During the School Day
Contact the school nurse (or district nurse if there is no nurse in the building) to inquire what records the new building will have on your child’s medications. Find out who will be responsible for giving your child the medication, and then contact them to ask whether they call the classroom to send your child down if your child forgets to go to them. Be sure to send in the medication in a labeled pharmacy bottle with a prescription from the physician authorizing them to administer the medication.
Throughout the School Year
Keep the school apprised of changes in your child’s medication, even if it is taken only at home. If you do not want the teacher to know about a particular change because you want to see if they detect any change if they do not know there’s been a medication change, that’s fine, but be sure to let the school nurse know and just ask the nurse not to tell the teacher unless there appears to be a problem from the new medication.