Vigilance regulation as predictor of response to Psychostimulants in adultpatients with ADHD

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 121

Inclusion Criteria

1. diagnosis of ADHD and ASRS-v1.1 part A cut-off 4 of 6
2. ADHD-symptoms existing since childhood (WURS-k >= 30)
3. >= 18 years
4. legal capacity
5. written informed consent of the patient
6. knowledge of german language
7. Intelligence test (MWT-B): IQ >= 85
8. willingness to breakfast and lunch

Exclusion Criteria

1. previous therapy with psychostimulants during the last 52 weeks before screening
2. 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)
3. 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

4.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

5. seizures in medical history
6. EEG findings suggest seizure
7. clinically relevant renal dysfunction (dialysis-dependent kidney
insufficiency)
8. clinically relevant hepatic disease (SGOT and/or SGPT greater > 2x
upper normal value)
9. lack of compliance
10. Pregnant or nursing women. Fertile women (within 2 years of their last
menstruation) without appropriate contraceptive measures.
11. participation in other interventional trials
12. closure relationship to investigator / sponsor
13. concomitant medication with psychotropic substance

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The lability index is determined using the VIGALL-algorithm based on<br>vigilance-EEGs. Individual vigilance cases are assigned to three<br>prototypical types of vigilance regulation (stable and physiological<br>vigilance regulation vs. unstable vigilance regulation). It will be<br>determined, if there is a relationship between stable/unstable vigilance<br>regulation and treatment success/failure. A therapy ist successful, if<br>total score of CAARS-S:L decreased 4 weeks after the end of titration<br>>30% by comparison to baseline.

Secondary Outcome Measures

Name	Time	Method

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