The effect of methylphenidate (Ritalin®) on the severity of stuttering.

Phase 1

Conditions: Stuttering
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-005146-55-BE

Lead Sponsor: Vakgroep Huisartsgeneeskunde Vrije Universiteit Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 30

Inclusion Criteria

Men
Developmental stuttering
18 years or older

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Psychological disorders: depression, psychosis, bipolar disorder.
Psychogenic of neurogenic stuttering
Adhd.
Narcolepsy.
Use of methylphenidate (now or in the past).
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: repeats, sounds, syllables, words, middle positions, blockades, audible, silences, stress;Timepoint(s) of evaluation of this end point: Before start administration, and after 2 weeks administration of 20 mg methylphenidate per day. Before start placebo and after 2 weeks of placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Subjective effect of methylphenidate on stuttering.;Timepoint(s) of evaluation of this end point: Before start administration, and after 2 weeks administration of 20 mg methylphenidate per day. Before start placebo and after 2 weeks of placebo.