Vigilance regulation as predictor of response to Psychostimulants in adult patients with ADHD

Phase 1

• Conditions: Attention deficit-hyperactivity disorder; MedDRA version: 20.0Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-000488-15-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-07
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified