CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Methylphenidate, non-retard +1 moredrug
Likely dose
Methylphenidate, non-retard 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01351272
NCT01351272Phase 3Completed
CompareCT.gov

Genetic Modulation of Functional Brain Activity of Attention-deficit/Hyperactivity Disorder-related Working Memory Processes

Wuerzburg University Hospital·interventional·Posted May 10, 2011·Updated Aug 15, 2024

In Brief

A Phase 3 clinical trial evaluating Methylphenidate, non-retard and Placebo for ADHD. Completed, enrolled 41 participants across 1 site.

Detailed Summary

In this study the investigators will measure the functional brain activity of adult Attention Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype, during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic effect of MPH treatment on cognitive functions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsADHD
CountriesGermany
CollaboratorsGerman Research Foundation

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2011
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago

Interventions

Methylphenidate, non-retarddrug

Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.

Placebodrug