Attention deficit-hyperactivity disorder MedDRA version: 20.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Medikinet adult 10 mg Hartkapseln, retardiert
Product Name: Methylphenidate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METHYLPHENIDATE
CAS Number: 113-45-1
Concentration unit:
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - diagnosis of ADHD and ASRS-v1.1 part A cut-off 4 of 6 - ADHD-symptoms existing since childhood (WURS-k >= 30) - >= 18 years - legal capacity - written informed consent of the patient - knowledge of german language - Intelligence test (MWT-B): IQ >= 85 - willingness to breakfast and lunch Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - previous therapy with psychostimulants during the last 52 weeks before screening - diagnosis or anamnesis of psychiatric comorbidity and –symptoms: a. severe depression (according to ICD F32.2/F32.3; F33.2; F33.3) b. Anorexia nervosa / anorectic disorder (SKID-I) c. suicidal tendencies d. psychotic symptoms (SKID-I) e. severe affective disorders (SKID-I) f. mania (SKID-I) g. schizophrenia (SKID-I) h. psychopathological / Borderline-personality-disorders (SKID-II) i. severe and episodic (Typ I) bipolar affective disorders (SKID-I) (which are not well controlled) j. dependence on alcohol, medication or drug during the last 6 months or manifest drug abuse (SKID-I) k. diagnosis of tic disorder l. acute severe panic disorder or generalised anxiety disorder (SKID-I) - contraindication for therapy or according to SmPC: a. hypersensitivity to methylphenidate or other components of the IMP b. glaucoma c. pheochromocytoma d. during the therapy or within 14 days after cessation of treatment with MAO-inhibitor e. hyperthyroidism or thyrotoxicosis f. clinically relevant cardiovascular diseases (severe hypertension; heart failure; arterial occlusive disease; angina pectoris; haemodynamic significant, congenital cardiac defect; cardiomyopathy; myocardial infarction; arrhythmia of life-threatening potential; channelopathies) g. cerebrovascular disease (cerebral aneurysm; abnormal blood vessels including vasculitis or apoplex) h. pronounced anacidity of stomach with pH>5.5; under therapy with H2 receptor inhibitor or therapy with antacids - medication, which can lead to interaction in case of concomitant use: a. drugs, which increase blood pressure b. halogenated narcotics c. centrally effective alpha-2-agonists d. dopaminergic agents e. H2-inhibitors f. antacids / proton pump inhibitor - seizures in medical history - EEG findings suggest seizure - clinically relevant renal dysfunction (dialysis-dependent kidney insufficiency) - clinically relevant hepatic disease (SGOT and/or SGPT greater > 2x upper normal value) - lack of compliance - Pregnant or nursing women. Fertile women (within 2 years of their last menstruation) without appropriate contraceptive measures. - participation in other interventional trials - closure relationship to investigator / sponsor - concomitant medication with psychotropic substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the trial is the investigation, if an unstable vigilance regulation in the EEG prior to medication (measured on VIGALL classification) predicates the response of therapy with methylphenidate in ADHD. The therapeutic target is a >30%-reduction of CAARS (CAARS-S:L - Conners’ Adult ADHD Rating Scales-Self-Report: Long Version).;Secondary Objective: In the secondary objectives of clinical trial should be investigated, if - the intensity of vigilance regulation is related to therapeutic effect Furthermore will be examined within the final examination compared with baseline and depending on therapeutic effect, whether and how the therapy - has an effect on the quality of life, measured by „Quality of life questionnaire“ (WHOQOL-BREF) - has an effect on interpersonal problems, measured by “Inventar zur Erfassung interpersonaler Probleme” - has an effect on ADHD symptoms, measured by ASRS-v1.1 (Adult ADHD Self-Report Scale) ;Primary end point(s): The lability index is determined using the VIGALL-algorithm based on vigilance-EEGs. Individual vigilance cases are assigned to three prototypical types of vigilance regulation (stable and physiological vigilance regulation vs. unstable vigilance regulation). It will be determined, if there is a relationship between stable/unstable vigilance regulation and treatment success/failure. A therapy ist successful, if total score of CAARS-S:L decreased 4 weeks after the end of titration >30% by comparison to baseline.;Timepoint(s) of evaluation of this end point: 4 weeks after end of titration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The predictive value of lability index for changes of CAARS-Score from baseline until last visit is determined. Sex, dose of methylphenidate and weight will are considered. - Changes of quality of life, measured by „Quality of life questionnaire“, are determined depending on therapy success and other covariats. - Changes of interpersonal problems, measured by „ Inventar zur Erfassung interpersonaler Probleme“, are determind depending on therapy success and other covariats. - Changes of ADHD symptoms, measured by ASRS-v1.1 (Adult ADHD Self-Report Scale), are determind depending on therapy success and other covariats. - Therapy success, measured by CGI, is determined after adjusting for covariats. - Changes of depressive symptoms, measured by MADRAS, are determind depending on therapy success and other covariats. - Control of possible covariats of vigilance regulation (sleep, depression, ADHD symptoms, substance use, daytime sleepiness, chronotype);Timepoint(s) of evaluation of this end point: 4 weeks after end of titration | — |
Countries
Germany
Contacts
Public ContactOA Dr. med. Maria Strauß
Department of Psychiatry of University of Leipzig
Outcome results
None listed