ADHD ODD MedDRA version: 12.1 Level: LLT Classification code 10064104 Term: ADHD
Conditions
Interventions
Trade Name: Ritalin
Product Name: methylphenidate
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Accare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of both sexes, of any ethnic and cultural background, ages 2;6 to 5;6 years. 2. At time of referral A DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ADHD any subtype including ADHD-Not Otherwise Specified. 3. At time of referral presence of oppositional behavior as evidenced through either a DSM-IV (American Psychiatric Association, 1994) consensus diagnosis of ODD, or Conduct Disorder, or Disruptive Behavior Disorder Not Otherwise Specified, or a baseline mother’s ECBI score > 114 and identification of minimally three target problem behaviors. 4. Previous treatment through PMT has resulted in less than 30% reduction on the ECBI, or on the Externalizing scale of the Teacher Report Form for Ages 1½-5 (TRF/1½-5) or has resulted in a rating of less than improved on the Clinical Global Impression Scale of improvement by at least two of the three raters (parent, teacher, or clinician). 5. Full Scale IQ equivalent of >70. 6. The same primary caretaker for at least 6 months before inclusion. 7. Parents have provided informed consent to participate in the study, in accordance with Dutch ethical regulations. 8. Systolic and diastolic blood pressure below 95th percentile for age and gender. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous PCIT; other forms of previous treatments are acceptable, including the use of previous psychotropic medication. 2. The child has a major medical condition that would interfere with involvement in a long-term study or could be affected negatively by methylphenidate. 3. Ongoing psychosocial treatment or ongoing treatment with psychotropic medication. 4. Inability of the parent to understand or follow study instructions. 5. Patients whose families anticipate a move outside the geographic range of the investigative site or who plan extended travel inconsistent with the recommended visit intervals. 6. Use of any other psychotropic medication or has taken an investigational drug in the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Caretaker's Eyberg Child Behavior Inventory;Main Objective: The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered PMT. ;Secondary Objective: As secondary objective we aim to identify predictors and moderators of treatment response, which include both parental and children’s characteristics. | — |
Countries
Netherlands
Outcome results
None listed