Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT06491160
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and FMRI BOLD Signal Changes in Impulsive Patients
Sponsor:
Simone Grimm
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: