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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03187353
The ClinicalTrials.gov registry entry for NCT03187353 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03187353 reports 0 study locations.
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.
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