EUCTR2006-002716-94-IS
Active, not recruiting
Phase 1
AD/HD diagnosis through EEG, a pilot study
ConditionsAttention Deficit - Hyperactivity Disorder (AD/HD)MedDRA version: 8.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorder
DrugsRitalin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Attention Deficit - Hyperactivity Disorder (AD/HD)
- Sponsor
- Mentis Cura ehf.
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects:
- •–Between 6\-8 years of age
- •–On the parent\-completed SDQ, scores on the four proplem subscales (Hyperactivity, Emotional Problems, Conduct Problems, Peer Problems) should not exceed 1\.0 standard deviation above the age appropriate mean. On the AD/HD Rating scale\-IV, Inattention and Hyperactivity subscores should not exceed one standard deviation above the mean. The means and standard deviations mentioned here refer to Icelandic norms.
- •AD/HD subjects:
- •–Between 6\-8 years of age
- •–Recently diagnosed with AD/HD according to DSM\-IV
- •–Other possibilities have been exhausted and treatment using methylphenidate (Ritalin®) is the only viable option left
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
Exclusion Criteria
- •–Individual has Tourette syndrome
- •–Individual suffers from psychosis
- •–Individual suffers from mental retardation
- •–Individual allergic to the investigational material
- •–Individual is receiving treatment for other diseases affecting the central nervous system
- •–Hypersensitivity to methylphenidate or any other component in the Ritalin® formulation
- •–Participation in another investigational study at the same time
Outcomes
Primary Outcomes
Not specified
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