Effect of methylphenidate formulation on attention deficit hyperactivity disorder (ADHD)-patients' adherence to medical treatment. A comparison of Medikinet retard® (extended-release [ER]) once daily and Medikinet® (immediate-release [IR]) twice daily in children and adolescents diagnosed with ADHD

Phase 4

Completed

• Conditions: Children and adolescents diagnosed with attention deficit hyperactivity disorder (ADHD); Mental and Behavioural Disorders; Hyperkinetic disorders

• Registration Number: ISRCTN93724387
• Lead Sponsor: Johannes Gutenberg University of Mainz (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-30
• Study Completion: 2010-08-15
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Subjects meeting all of the following criteria are considered for enrolment into the trial:
1. Written informed consent (separately for children aged 6-11 years and 12-17 years)
2. Children and adolescents of both sexes aged 6 - 17 years
3. Confirmed diagnosis of ADHD by semi structured-clinical interview (K-SADS)
4. The ADHD Rating Scale-IV (ADHDRS-IV) Parent Version (18-Item-Scale) raw score >=1.5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)
5. Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD Rating Scale (ADHD-RS) under medication, compared to retrospective ADHD-RS without medication within the past 6 months
6. Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®
7. Sufficient knowledge of the German language
8. Adequate contraception in case of sexual activity

Exclusion Criteria

Subjects fulfilling any of the following criteria will not be enrolled into the trial:
1. Contraindications against methylphenidate
1.1. Allergy or hypersensitivity against methylphenidate or methylphenidate derivate or any other ingredient of the product
1.2. Severe anxiety disorder, high tenseness or arousal, depression, psychosis
1.3. Hyperthyroidism
1.4. Glaucoma
1.5. Thyreotoxicosis
1.6. Severe angina pectoris
1.7. Cardiac arrhythmia
1.8. Severe hypertension
1.9. Heart insufficiency
1.10. Myocardial infarction
1.11. Known substance abuse or alcoholism
1.12. Intake of Monoamine oxidase (MAO) inhibitor at the same time or during the last 14 days
1.13. Tic-disorder or tic disorder in family history
1.14. Pregnancy, lactation
1.15. Marked gastric anacidity
2. Previous stable methylphenidate intake more than twice daily
3. All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.
4. All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
5. Pathological results for vital signs, blood pressure and pulse
6. Reported pathological results for
6.1. Electrocardiogram (ECG) during the last 12 months
6.2. Differential blood count and hepatic metabolism during the last 6 months
7. Indication for hospitalization
8. Suicidality (assessed by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10, Score >=3)
9. IQ <70 (clinically assessed)
10. Any psychotropic co-medication
11. Detention in an institution on official or judicial ruling
12. Unwillingness to transmit pseudonym data according to German regulations
13. Simultaneous participation in another clinical trial according to German Drug Law (AMG)

Study & Design

• Study Type: Interventional
• Study Design: Not specified