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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68384912

Enrollment

180

Registered

2006-05-09

Start date

2004-06-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Hyperkinetic disorder, mental retardation (intellectual disability) Mental and Behavioural Disorders Hyperkinetic disorder

Interventions

180 children between ages 7 and 15 years with moderate-severe learning disability and hyperkinetic disorder will be invited to take part in a randomized double-blind trial of methylphenidate versus pl

Eligibility

Sex/Gender

All

Inclusion criteria

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

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c. History of psychotic, bipolar or severe obsessive compulsive disorder d. Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment) e. History of intolerance to stimulant medication f. Child poses a significant risk of suicidal or homicidal behaviour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

Design outcomes

Primary

Measure	Time frame
Conners parent and teach questionnaires, short form: ADHD and hyperactivity indices	—

Secondary

Measure	Time frame
1. Adverse events (other behaviours questionnaire plus any others noted) 2. Aberrant behaviour questionnaire 3. Quality of Life (Cadfield) 4. Parental Resport on Neuropsychiatric Symptoms (PONS)	—

Countries

United Kingdom

Outcome results

None listed

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