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Atomoxetine in Patients With Tourette's Syndrome

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04354103
Acronym
ATO-TS
Enrollment
5
Registered
2020-04-21
Start date
2022-05-31
Completion date
2024-01-19
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette Syndrome

Keywords

Impulsivity

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.

Interventions

DRUGAtomoxetine

Atomoxetine

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Impulsive state8 weeksThe primary outcome is the variation of impulsive state (%) before and after chronic administration of atomoxetine, as measured with quantitative tool (CANTAB)

Secondary

MeasureTime frameDescription
Cognition, anxiety, depression, severity of tics and compulsive disorders Tolerance8 weeksThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026