Atomoxetine in Patients With Tourette's Syndrome

Tourette Syndrome Clinical Trial

— ATO-TS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04354103
• Other study ID #: 2019-004455-36
• Status: Terminated
• Phase: Phase 2
• Start date: May 31, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: November 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Atomoxetine
Atomoxetine

Locations

Country	Name	City	State
France	Hospices civils de Lyon	Lyon
France	AP-HP La Pitié Salpêtrière	Paris
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

References & Publications (4)

Allen AJ, Kurlan RM, Gilbert DL, Coffey BJ, Linder SL, Lewis DW, Winner PK, Dunn DW, Dure LS, Sallee FR, Milton DR, Mintz MI, Ricardi RK, Erenberg G, Layton LL, Feldman PD, Kelsey DK, Spencer TJ. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology. 2005 Dec 27;65(12):1941-9. doi: 10.1212/01.wnl.0000188869.58300.a7. — View Citation

Ansquer S, Belin-Rauscent A, Dugast E, Duran T, Benatru I, Mar AC, Houeto JL, Belin D. Atomoxetine decreases vulnerability to develop compulsivity in high impulsive rats. Biol Psychiatry. 2014 May 15;75(10):825-32. doi: 10.1016/j.biopsych.2013.09.031. Epub 2013 Oct 11. — View Citation

Chamberlain SR, Del Campo N, Dowson J, Muller U, Clark L, Robbins TW, Sahakian BJ. Atomoxetine improved response inhibition in adults with attention deficit/hyperactivity disorder. Biol Psychiatry. 2007 Nov 1;62(9):977-84. doi: 10.1016/j.biopsych.2007.03.003. Epub 2007 Jul 17. — View Citation

Kehagia AA, Housden CR, Regenthal R, Barker RA, Muller U, Rowe J, Sahakian BJ, Robbins TW. Targeting impulsivity in Parkinson's disease using atomoxetine. Brain. 2014 Jul;137(Pt 7):1986-97. doi: 10.1093/brain/awu117. Epub 2014 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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