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NCT03187353 · ClinicalTrials.gov registry record · Phase 4
IMProving Executive Function Study
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 69
- Enrollment target
NCT03187353: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT03187353 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 69 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187353, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 69 participants
- Enrollment target
Study Summary
This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who report onset of EF difficulties after oophorectomy. This study involves magnetic resonance imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of the study drug and placebo capsules. UPDATE: We have recently updated this protocol (09/2020) to offer a remote version of the study that can be completed entirely from the participant's home. This alternate version of the study eliminates travel, the MRI, and blood draws.
Primary Outcome
The Brown Attention Deficit Disorder Scale (BADDS) (Brown, 1996) is a 40-item questionnaire that assesses five subscales of executive functioning. For each item in the questionnaire, participants reported the extent to which it had been a problem over the last six months (0 = never, 1 = once a week or less, 2 = twice a week, or 3 = almost daily). Total BADDS scores can range from 0-120, with higher scores indicating more self-reported difficulties with executive functioning. Outcome measures are
Interventions
- DRUG Placebo oral capsule
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-09-22 |
| Est. Completion | 2022-04-30 |
| Phase | Phase 4 |
What the finished NCT03187353 record still lists
NCT03187353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03187353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03187353 about?
NCT03187353 is a clinical study titled "IMProving Executive Function Study". This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who report onset of EF difficulties after oophorectomy. This study involves magnetic resonance imaging (MRI) to see how LDX affe...
What is the current status of trial NCT03187353?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 69 participants. The study started on 2017-09-22. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT03187353?
The interventions under investigation include: Placebo oral capsule (DRUG), Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT03187353?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03187353's enrollment target sits among peer trials
69 1070th of 2000 higher than 925 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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