The effect of methylphenidate (Ritalin ®) on the severity of stuttering.
- Conditions
- stutteringTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-004206-26-BE
- Lead Sponsor
- Vakgroep Huisartsgeneeskunde VUB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Men and women
development Stuttering
At least 18 years old
Are the trial subjects under 18? no
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Psychological disorders: depression, psychosis, bipolar disorder
Psychogenic or neurogenic stuttering
Children under 18 years
ADHD
narcolepsy
Use of methylphenidate (now or in the past)
Pregnant or breastfeeding
AHT (blood pressure above 140/90)
Use of benzodiazepines, neuroleptics such as haloperidol, amphetamines, anti-emetics such as metoclopramide and domperidone, L-dopa, MAO inhibitors
Stroke or TIA
hyperthyroidism
Cocaine or other drug use (now or in the past)
Drug addiction (now or in the past)
glaucoma
alcoholism
Known liver disease
epilepsy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does methylphenidate effect on the severity of developmental stuttering in adults?;Secondary Objective: Not applicable;Primary end point(s): Measuring the number of :<br>repeats<br>sounds<br>syllables<br>words<br>Middle Positions<br>blockades<br>Audibles<br>silences<br>stress;Timepoint(s) of evaluation of this end point: before administration of a single dose and 3 hours after the administration
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: NA