Atomoxetine in Patients With Tourette's Syndrome

Phase 2

Terminated

• Conditions: Tourette Syndrome
• Interventions: Drug: Atomoxetine

• Registration Number: NCT04354103
• Lead Sponsor: Poitiers University Hospital

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.

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2022-05-31
• Status Verified: 2023-11
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with Tourette's syndrome	Atomoxetine	Atomoxetine in Patients With Tourette's Syndrome

Primary Outcome Measures

Name	Time	Method
Impulsive state	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 Outcome Measures

Name	Time	Method
Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance	8 weeks	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.

Trial Locations

Locations (3)

Hospices civils de Lyon; 🇫🇷 Lyon, France

CHU Poitiers; 🇫🇷 Poitiers, France

AP-HP La Pitié Salpêtrière; 🇫🇷 Paris, France