E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064104 |
E.1.2 | Term | ADHD |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
As secondary objective we aim to identify predictors and moderators of treatment response, which include both parental and children’s characteristics. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Caretaker's Eyberg Child Behavior Inventory |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Parent Child Interaction Therapy |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |