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Medication Optimization for ADHD: MOVA study. Implementation and evaluation of double-blind placebo-controlled titration in clinical practice

Medication Optimization for ADHD: MOVA study. Implementation and evaluation of double-blind placebo-controlled titration in clinical practice - MOVA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46942
Enrollment
140
Registered
2019-01-09
Start date
2017-05-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD attention-deficit/hyperactivity disorder

Interventions

The children in the control arm will have a gradual titration of methylphenidate, according to the protocol of the participating centers. The children in the placebo-controlled double-blind titratio
ADHD
methylphenidate
randomized controlled trial

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: children between the age of 6 and 12 with a DSM-based ADHD diagnosis, with a clinical indication to start pharmacological therapy with short-acting methylphenidate

Exclusion criteria

Exclusion criteria: - counter-indication for the start-up of methylphenidate (e.g. cardiac problems) - treated with MPH in the last 4 weeks.

Design outcomes

Primary

MeasureTime frame
The primary outcome measures are: -number of placebo and non-responders detected -ADHD symptoms measured with questionnaires -side effects measured with questionnaires

Secondary

MeasureTime frame
The secondary outcome measures are: -satisfaction of parents, teachers and therapists on the titration method -symptoms of CD and ODD, social-emotional functioning

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)