Apathy in Tourette Syndrome and Changes in Quality of Life

Tourette Syndrome Clinical Trial

Official title:

Apathy in Tourette Syndrome and Changes in Quality of Life - Effect of Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765178
• Other study ID #: IRB201500989
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: July 3, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tourette syndrome is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. Apathy has not been widely studied in patients with Tourette syndrome. Apathy can result in decrease in self-care and disease control. In this study investigators will compare the occurrence of apathy in the adolescent Tourette syndrome population (at the UF center for movement disorders and Neurorestoration) to an age and gender matched control population. Investigators will also assess the role of commonly used medications in the Tourette population (neuroleptics and selective serotonin receptor inhibitors) in the occurrence of apathy.

Description:

Tourette syndrome(TS) is a complex neuropsychological disorder with both motor and vocal tics associated with multiple psychological co-morbidities. The most common co-morbidities include obsessive compulsive disorder (OCD), attention deficit and hyperactivity disorder (ADHD) and depression. Apathy has not been extensively studied in the Tourette syndrome population. Apathy is currently defined as reduced motivation, with symptoms in at least two of three domains of reduced initiative, reduced interest and/or reduced emotional responsiveness. A study assessed the prevalence of apathy in multiple movement disorders and reported that apathy is much more common in disorders associated with slowed movements like Parkinson disease while less common in disorders with increased movements like Huntington disease and Tourette syndrome in adults. However, no apathy studies in adolescent patients with Tourette syndrome are published. Disengagement from treatment may affect health outcomes in other disease states. Apathy has significant effects on the quality of life and health outcomes in many patients. Apathy can be a direct manifestation of the neuropsychological process (intrinsic to the disease) or can be secondary to medication side effects most notably anti-dopaminergic agents and some reports of selective serotonin receptor inhibitors (SSRI). Further attention to the prevalence and impact of apathy in the adolescent Tourette syndrome population is needed to explore if this may be a factor influencing TS management and ultimately Quality of life (QOL). Multiple psychotropic medications are used in the management of tics as well as the psychological co-morbidities. How these medications affect apathy prevalence in Tourette syndrome patients is not known.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• Diagnosis: Tourette syndrome

• Age: 12-16 years

• Followed at the CMDNR

Exclusion Criteria:

• History of cerebral palsy or traumatic brain injury

Related Conditions & MeSH terms

• Apathy
• Syndrome
• Tourette Syndrome

Intervention

Other:
• Children's Motivation Scale
A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
• Yale Global Tic Severity Scale (YGTSS)
Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
• Studies Depression Scale for Children (CES-DC)
Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from "not at all" to "a lot." Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents
• Gilles de la Tourette Syndrome Quality Of Life scale
Clinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive).
• Demographic Data
Data will be collected including: age, age at disease onset, gender, current medication regimen and presence of co-morbidities (like a diagnosis of ADHD, OCD, depression or insomnia).

Locations

Country	Name	City	State
United States	UF Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Motivation Scale	A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.	Day 1
Secondary	Yale Global Tic Severity Scale (YGTSS)	Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.	Day 1
Secondary	Studies Depression Scale for Children (CES-DC)	Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from "not at all" to "a lot." Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents	Day 1
Secondary	Gilles de la Tourette Syndrome Quality Of Life scale	Clinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive).	Day 1