Atomoxetine in Patients With Tourette's Syndrome

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.

Detailed Description
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High impulsivity characterizes severe forms of Tourette's syndrome, in which motor and vocal tics are associated with various neuropsychiatric disorders as compulsive disorders, difficult to manage and impairing quality of life of patients and their family. Previous preclinical study and clinical studies in attention-deficit hyperactivity disorder and Parkinson's disease demonstrate that atomoxetine, a selective noradrenaline reuptake inhibitor, improves response inhibition in high impulsive individuals. However, there is no suffisant data in Tourette's syndrome. The purpose of this pilot study is to evaluate the effects of Atomoxetine on impulsivity in 10 to 35 years old patients with Tourette's syndrome.

Official Title
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A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome

Conditions
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Tourette Syndrome

Intervention / Treatment
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* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine The use of effective contraception or abstinence for subjects of reproductive age Written informed consent Exclusion Criteria: Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria. Actual severe depression Allergy to one of the constituents Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma IMAO treatment discontinued less than 2 months or contra-indicated associated treatment

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with Tourette's syndrome<br>Atomoxetine in Patients With Tourette's Syndrome | Drug: Atomoxetine<br>* Atomoxetine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impulsive state | The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance | The secondary outcomes are the effects of Atomoxetine in cognition, anxiety, depression, severity of tics and compulsive disorders, as mesured with autoquestionnaries. The investigators also evaluate the tolerance of chronic administration of atomoxetine in patients with Tourette's syndrome. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulsivity