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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 is a Phase 4 study that was terminated before completion, run by University of California, Davis. The registered enrollment target is 6 participants.
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.
Interventions
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02170298
The ClinicalTrials.gov registry entry for NCT02170298 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lisdexamfetamine is the first listed.
NCT02170298 reports 0 study locations.
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.
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