Medication Optimization for ADHD: MOVA study

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2016-002474-13-NL
• Lead Sponsor: Innovatiefonds Zorgverzekeraars

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-13
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1.ADHD diagnosis according to the DSM-V criteria (all subtypes), by a therapist;
2.Indication for treatment with short-acting MPH;
3.Age between 6 and 12 years;
4.Attending (any type of) primary school;
5.Parents and teachers master the Dutch language to such a degree that they may read and understand the questionnaires that need to be filled out as part of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1.Counter-indication for the start-up of MPH. For example, MPH can be contraindicated in patients with Gilles de la Tourette, cardiac problems, or bipolar disorder.
2.Treated with MPH in the last 6 months, in order to be able to evaluate the children's behavior over a period without medication at baseline (the start of the RCT).

Study & Design

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