Evaluation of the effect of Atomoxetine on impulsive state of High impulsive Tourette’s patients.

Evaluation of the effect of Atomoxetine on impulsive state of High impulsive Tourette’s patients. - ATO-TS

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004455-36-FR

Enrollment

Registered

2019-11-26

Start date

2020-03-10

Completion date

Unknown

Last updated

2020-08-25

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

Conditions

High impulsive Tourette’s syndrome patients MedDRA version: 20.0 Level: LLT Classification code 10042808 Term: Syndrome Gilles de la Tourette System Organ Class: 100000004850

Interventions

Trade Name: STRATTERA® (Atomoxetine) Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: Tourette’s patients from 10 to 35 years old diagnosed according to the criteria of DSM-V, with high impulsive trait, and who freely consent to this study Healthy subjects, of normal development, free from any neuropsychiatric pathology, matched 1:1 in age and sex to the patients recruited in this study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Other psychiatric disease of the axis I of DSM-IV, severe depression, allergic reactions to chemical coumpounds of the treatment or medical contraindications of atomoxetine, concommitent treatments contraindicated with atomoxetine (IMAO) interrupted from less tha 2 weeks or Clonidine or Methyphenidate interrupted from less than 1 month

Design outcomes

Primary

Measure	Time frame
Main Objective: The main goal of this study is to assess the effect of 8 weeks of treatment with atomoxetine, a selective recapture noradrenaline inhibitor, on impulsive state measured with the Stop signal task (Cambridge Cognition).;Secondary Objective: The secondary objectives of this study are to assess the safety and therapeutic effect of 8 weeks of treatment with atomoxetine on other forms of impulsivity (cognitive impulsivity), cognition, mood and severity of tics. ;Primary end point(s): Stop Signal Reaction Time variation (ms);Timepoint(s) of evaluation of this end point: 10 weeks = Visit 6 (J70) compared to V1 (J0)	—

Measure

Time frame

Main Objective: The main goal of this study is to assess the effect of 8 weeks of treatment with atomoxetine, a selective recapture noradrenaline inhibitor, on impulsive state measured with the Stop signal task (Cambridge Cognition).;Secondary Objective: The secondary objectives of this study are to assess the safety and therapeutic effect of 8 weeks of treatment with atomoxetine on other forms of impulsivity (cognitive impulsivity), cognition, mood and severity of tics. ;Primary end point(s): Stop Signal Reaction Time variation (ms);Timepoint(s) of evaluation of this end point: 10 weeks = Visit 6 (J70) compared to V1 (J0)

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Secondary

Measure	Time frame
Secondary end point(s): 1- Efficacy : compared to baseline, effect of 8 weeks of treatement with atomoxetine on : -percentage of commission errors on the Stop Signal Task (SST) -Cognitive impulsivity in the Cambridge Gambling Task (CGT) (delay aversion, bit, deliberation time, risk taking, risk adjustment, decision making quality) -% antisaccades measured with electro-oculograph SURICOG (Eye Brain T2) -Stroop -Rey figure -Severity of tics, measured with YGTSS and Rush video scale -Severity of TOCs, measured with YBOCS -Other compulsive disorders -Severity of anxiety measured with STAI or depression with BDI 2/ tolerance 3/ For functional MRI sub-study (only patients recruted in CHU de Poitiers) : Establish an anatomo-clinical correlation in functional MRI of the effect of atomoxetine in impulsive state measured with the Stop Signal Task. ;Timepoint(s) of evaluation of this end point: 10 weeks = Visit 6 (J70) compared to V1 (J0)	—

Measure

Time frame

Secondary end point(s): 1- Efficacy : compared to baseline, effect of 8 weeks of treatement with atomoxetine on : -percentage of commission errors on the Stop Signal Task (SST) -Cognitive impulsivity in the Cambridge Gambling Task (CGT) (delay aversion, bit, deliberation time, risk taking, risk adjustment, decision making quality) -% antisaccades measured with electro-oculograph SURICOG (Eye Brain T2) -Stroop -Rey figure -Severity of tics, measured with YGTSS and Rush video scale -Severity of TOCs, measured with YBOCS -Other compulsive disorders -Severity of anxiety measured with STAI or depression with BDI 2/ tolerance 3/ For functional MRI sub-study (only patients recruted in CHU de Poitiers) : Establish an anatomo-clinical correlation in functional MRI of the effect of atomoxetine in impulsive state measured with the Stop Signal Task. ;Timepoint(s) of evaluation of this end point: 10 weeks = Visit 6 (J70) compared to V1 (J0)

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Countries

France

Contacts

Public ContactFanny ABRIAT

CHU DE POITIERS

fanny.abriat@chu-poitiers.fr+330549443796

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026