A clinical trial of methylphenidate and lisdexamphetamine treatment in adults with attention-deficit hyperactivity disorder

A head-to-head randomized clinical trial of methylphenidate and lisdexamphetamine treatment for executive functions and global functioning in adults with ADHD - A clinical trial with two psychostimulants of Central Nervous System in adults with ADHD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000368-14-SE

Enrollment

120

Registered

2017-03-30

Start date

2017-12-14

Completion date

Unknown

Last updated

2018-12-04

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

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Trade Name: Elvanse Product Name: Elvanse Pharmaceutical Form: Capsule, hard Trade Name: Concerta Product Name: Concerta Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults 18-45 years of age Clinical diagnosis ADHD of any subtype and DSM 5 presentation Intellectual ability in the normal range, according to clinical judgment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Physical or mental limitations that make cognitive evaluations unsuitable. Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject. Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable. Substance abuse. Subjects who has previously been treated with ADHD medication.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives: to compare Concerta (®), first-line treatment vs adult ADHD, with lisdexamfetamine (®), approved alternative medication with respect to the effect on: clinical symptomathology of ADHD; basal executive functions; global functioning; compliance to the treatment. ;Secondary Objective: Secondary objectives: to analyze possible differences (before and during treatment) with respect to the executive functions in adults with ADHD versus healthy / untreated subjects.;Primary end point(s): 6 moths;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: Primary objectives: to compare Concerta (®), first-line treatment vs adult ADHD, with lisdexamfetamine (®), approved alternative medication with respect to the effect on: clinical symptomathology of ADHD; basal executive functions; global functioning; compliance to the treatment. ;Secondary Objective: Secondary objectives: to analyze possible differences (before and during treatment) with respect to the executive functions in adults with ADHD versus healthy / untreated subjects.;Primary end point(s): 6 moths;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): 6 months;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Sweden

Contacts

Public ContactAffektiva kliniken, Sahlgrenska

Psykiatrimottagning Centrum

peter.sand@vgregion.se+46700816875

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026