Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)

Prof. Huss

Status and phase

Terminated

Phase 4

Conditions

ADHD

Treatments

Drug: Immediate release methylphenidate (Medikinet®)

Drug: Extended release methylphenidate (Medikinet retard®)

Study type

Interventional

Funder types

Other

Identifiers

NCT00852059

JoGu_KJP_ASTA-3285-26

Details and patient eligibility

About

This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS).

Study Design:

prospective
multi-centric
open-label
randomized
active-controlled trial

Full description

The study is designed as a prospective, multi-centric, open-label, randomized, active-controlled trial. ADHD-children and adolescents of both sexes, 6-17 of age, effectively treated with stimulants are recruited in two centres. Over a naturalistic run-in phase of four weeks adherence to medication taken before randomisation is measured. In the subsequent controlled clinical trial 50% of the participants are randomized to extended release (ER) methylphenidate (Medikinet retard®) applied with breakfast, 50% are randomized to immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (clinical trial). To optimize ecological validity, no double-dummy technique is applied; the allocation to either study arm is non-blinded.

According to the power calculation 106 patients will be randomized. The total duration of the study is 18 months. Starting with a run-in visit, each eligible patient is observed in the naturalistic run-in phase for four weeks. Subsequently, patients participate 100 days in the clinical trial starting with a baseline visit, an in between-visit and a final visit. Medical care is provided in the routine program of both study centres. To record the adherence, medication events are counted by Medication Event Monitoring System (MEMS).

Enrollment

32 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent (separately for children aged 6-11 years and 12-17 years)
Children and adolescents of both sexes aged 6 - 17 years
Confirmed diagnosis of ADHD by semi structured-clinical interview K-SADS
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)
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-RS under medication, compared to retrospective ADHD-RS without medication within the past 6 months.
Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®.
Sufficient knowledge of the German language
Adequate contraception in case of sexual activity

Exclusion criteria

Contraindications against methylphenidate
Previous stable methylphenidate intake more than twice daily
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.
All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
Pathological results for vital signs, blood pressure and pulse
Reported pathological results for ECG during the last 12 months
Reported pathological results for differential blood count and hepatic metabolism during the last 6 months
Indication for hospitalization
Suicidality (assessed by MADRS Item 10, Score ≥ 3)
IQ < 70 (clinically assessed)
Any psychotropic co-medication
Detention in an institution on official or judicial ruling
Unwillingness to transmit pseudonym data according to German regulations
Simultaneous participation in another clinical trial according to German Drug Law (AMG)