Patients having a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version). MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD
Conditions
Interventions
Trade Name: Ritalin LA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
CAS Number: 298599
Other descriptive name: Ritalin LA 20mg
Concentration unit: mg milligram
Sponsors
Dept. Child & Adolescent Psychiatrie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study: 1. Male patients aged 8-14 with Tanner stages 0 to 2 and a BMI between the 10th and 90th age percentile 2. Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version; see Appendix 3) 3. Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20 mg to 30 mg for one month before screening. 4. Patients with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the clinical trial (according to §40 Abs. 4 No. 4 AMG). Assent will be documented by the child’s signature on the consent form. 5. Health status: Patients must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam. 6. Patients meeting minimum intelligence requirements: In the opinion of the investigator the patient must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing(basic knowledge of reading, writing and calculating). 7. Patients already receiving behavioral therapies for HKS/ADHD may continue to do so during the course of the trial. 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: Exclusion Criteria: 1. Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis). 2. Patients with comorbid psychiatric or somatic conditions that may contraindicate treatment or confound efficacy or safety assessments. 3. Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g. • Tricyclic antidepressants, SSRIs except Fluoxetine, bupropion, clonidine, buspirone 2 weeks before randomization. • Atomoxetine 2 weeks before randomization. • Fluoxetine or antipsychotics 1 month before randomization. • Pemoline and amphetamines 1 week before randomization. 4. Patients with a known non-response to methylphenidate. 5. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. 6. Patients who are judged by the investigator as likely to be non-compliant with study procedures, including those with a suspected history of substance abuse, or patients living with a person diagnosed with a substance abuse disorder. 7. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 8. Patients with warnings, mentioned in the German Basic Prescribing Information of Ritalin LA® (Fachinformation, November 2002): anorexia, severe depression, anxiety disorder, Gilles de la Tourette-Syndrome, other tic disorder, hypertension, occlusive arterial diseases, severe stenocardia, tachycardiac arrhythmia, stroke, hyperthyroidism, increased intra-ocular pressure, hypertrophy of the prostate, known hypersensitivity to sympathomimetics, MAO-inhibitors. 9. Patients with a history of seizure disorder. 10. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the pharmacokinetic parameters and bioequivalence of Ritalin LA® compared to Medikinet® retard, both given as single oral o.d. doses of 20 mg over 7 days in children with ADHD.;Secondary Objective: The secondary objectives are to assess the efficacy, safety and tolerability of Ritalin LA® and Medikinet® retard and the association of these parameters with plasma levels.;Primary end point(s): Determination of the pharmacokinetic parameters and bioequivalence of Ritalin LA® compared to Medikinet® retard, both given as single oral o.d. doses of 20 mg over 7 days in children with ADHD. Bioequivalence of Ritalin LA® and Medikinet® has to be evaluated in rate und extent by Cmax, tCmax and AUC(0-inf) and calculated from the plasma concentration-time curve. The efficacy, safety and tolerability of Ritalin LA® and Medikinet® retard and the association of these parameters with plasma levels is evaluated by using Primary: SKAMP Combined rating performed at 25 minutes before and 0:50 h, 1:50 h, 2:50 h, 3:50 h, 5:50 h and 7:20 h after drug intake in a laboratory classroom setting. Secondary: SKAMP-Attention subscale and the SKAMP-Deportment subscale at 25 minutes before and 0:50 h, 1:50 h, 2:50 h, 3:50 h, 5:50 h and 7:20 h after drug intake in a laboratory classroom setting. | — |
Countries
Germany
Outcome results
None listed