A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Atomoxetine
- Conditions
- Tourette Syndrome
- Sponsor
- Poitiers University Hospital
- Enrollment
- 5
- Locations
- 3
- Primary Endpoint
- Impulsive state
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
patients with Tourette's syndrome
Atomoxetine in Patients With Tourette's Syndrome
Intervention: Atomoxetine
Outcomes
Primary Outcomes
Impulsive state
Time Frame: 8 weeks
The primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)
Secondary Outcomes
- Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance(8 weeks)