NCT06491160

Performance and FMRI BOLD Signal Changes in Impulsive Patients

A Trial to Explore Performance and FMRI BOLD Signal Changes During Impulsivity Tasks in Impulsive Patients with Attention Deficit Hyperactivity Disorder and Borderline Personality Disorder

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Simone Grimm · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study is a preceding study conducted to validate the methodology for assessing impulsivity by tasks and task-based fMRI measurements in patients with Attention Deficit Hyperactivity Disorder (ADHD) or Borderline Personality Disorder (BPD).

Detailed description

It is planned to conduct a clinical trial to test pharmacodynamic effects of a new drug under development for impulsivity including patients with ADHD or BPD. For the preparation of this planned trial, a preceding study will be conducted. The results of this preceding study will be needed to prepare and plan the upcoming proof-of-clinical-principle-study regarding behavioral effects, involved brain regions, effect sizes, patient experience, and task design. Testing and optimizing the study procedures in advance in this preceding study will help to define the objectives and endpoints of the planned pharmacodynamic trial.

Conditions

• Attention Deficit Hyperactivity Disorder
• Borderline Personality Disorder

Timeline

• Start date: 2024-08-06
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2024-07-08
• Last updated: 2025-01-03

Locations

1 site across 1 country: Germany