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

ADHD Clinical Trial

— ASTA  

Official title:

Effect of Methylphenidate Formulation on ADHD-patients` Adherence to Medical Treatment. A Comparison of Medikinet Retard® (ER) Once Daily and Medikinet® (IR) Twice Daily in Children and Adolescents Diagnosed With ADHD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852059
• Other study ID #: JoGu_KJP_ASTA-3285-26
• Status: Terminated
• Phase: Phase 4
• First received: February 25, 2009
• Last updated: May 6, 2014
• Start date: March 2009
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Immediate release methylphenidate (Medikinet®)
Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release
• Extended release methylphenidate (Medikinet retard®)
Treatment: methylphenidate applied with breakfast(once daily), extended release

Locations

Country	Name	City	State
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Huss

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)		100 days	No
Secondary	Number of non-adherent days measured by pill count		100 days	No
Secondary	Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS		100 days	No
Secondary	Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score		100 days	No
Secondary	The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score		100 days	No