A double-blind, placebo-controlled trial of methylphenidate in children with hyperkinetic disorder and moderate-severe learning disabilities

Completed

• Conditions: Hyperkinetic disorder, mental retardation (intellectual disability); Mental and Behavioural Disorders; Hyperkinetic disorder

• Registration Number: ISRCTN68384912
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Diagnosis of International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10) hyperkinetic disorder
2. Full-scale IQ 30-69 or age equivalent estimate
3. Living in catchment area of one of the participating centres
4. Child in stable care situation
5. Child regularly attending school (more than 75% of last school term)

Exclusion Criteria

1. Child currently in another trial of psychoactive medication
2. Household member with recent diagnosis of substance abuse
3. Severe limitation of child's mobility
4. Presence of a degenerative disorder
5. Medical conditions precluding methylphenidate as treatment of first choice, including:
a. Poorly controlled or uncontrolled epilepsy
b. Presence of tics or Tourette disorder
c. History of psychotic, bipolar or severe obsessive compulsive disorder
d. Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)
e. History of intolerance to stimulant medication
f. Child poses a significant risk of suicidal or homicidal behaviour
6. Another child in the family/household already enrolled in this study
7. Ongoing child protection concerns

Study & Design

• Study Type: Interventional
• Study Design: Not specified