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NCT02170298 · ClinicalTrials.gov registry record · Phase 4
Lisdexamfetamine's Effect In ADHD in the Brain and Cognition
A Phase 4 study, sponsored by University of California, Davis.
- Terminated
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT02170298: Clinical Trial Phase 4 study, sponsored by University of California, Davis.
NCT02170298 is a Phase 4 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02170298, a Phase 4 study, was terminated before completion, sponsored by University of California, Davis.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder. The investigators hypothesize that LDX is associated with 1a) decreased task-independent locus coeruleus (LC) activity; 1b) increased task-related activity in LC and the cognitive control network; 2) increased LC connectivity with the cognitive control network and 3) improved task performance and self-control. The investigators will test their hypotheses on fMRI data with linear contrasts of voxel-wise maps of parameter estimates (in both univariate and connectivity analyses). The investigators will also assess change in brain activity with the LDX in the LC and ventral tegmental areas (VTA) as we hypothesize that they are altered in ADHD and related to cognitive control and self-control dysfunction in ADHD. The investigators will use a repeated-measures, between-subject design to compare the effects of oral once daily LDX in a double-blind placebo-controlled randomized trial (RCT) on neural (fMRI) and behavioral correlates of cognitive control via a working memory and a reward - delay discounting task in adolescents and young adults. A new condition has been added which will use a within-subject comparison, cross-over design between a single dose of LDX versus a single dose of placebo.
Primary Outcome
Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.
Interventions
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
Why NCT02170298 stopped before completion
NCT02170298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Lisdexamfetamine is the first listed.
NCT02170298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02170298 about?
NCT02170298 is a clinical study titled "Lisdexamfetamine's Effect In ADHD in the Brain and Cognition". The purpose of this study is to identify the effects of lisdexamfetamine (LDX) on the neural and behavioral subcomponents of self-control, that is cognitive control and reward functioning, in adolescents and young adults with attention-deficit/hyperactivity disorder. The investigators hypothesize t...
What is the current status of trial NCT02170298?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2014-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02170298?
The interventions under investigation include: Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT02170298?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02170298's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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