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CNS Stimulant

Placebo oral capsule for Cognitive Impairment (IMPRES Trial)

Phase 4
Waitlist Available
Led By C. Neill Epperson, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

IMPRES Trial Summary

This trial tests whether Vyvanse improves executive functioning in postmenopausal women who report difficulties after oophorectomy. The study involves two 6-week trials of the study drug and placebo capsules, and uses MRI to see how LDX affects brain chemistry.

Eligible Conditions
  • Cognitive Impairment
  • Salpingo-Oophorectomy

IMPRES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brown Attention Deficit Disorder Scale (BADDS) Change Score (End of Trial Minus Baseline).
Secondary outcome measures
Brain Activation (BOLD Percent Signal Change)
Brain Activation (Glutamate Contrast)

IMPRES Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, then LisdexamfetamineExperimental Treatment2 Interventions
Participants will have a 50% chance of first receiving the placebo, beginning with 1 sugar pill and increasing up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. After a washout period of 2 weeks, they will begin active study medication at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks.
Group II: Lisdexamfetamine, then PlaceboExperimental Treatment2 Interventions
Participants will have a 50% chance of first receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. After a washout period of 2 weeks they will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral capsule
2010
Completed Phase 4
~2380
Lisdexamfetamine
2013
Completed Phase 4
~430390

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,999 Previous Clinical Trials
42,879,373 Total Patients Enrolled
C. Neill Epperson, MDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
IMProving Executive Function Study
2017. "IMProving Executive Function Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187353.
~9 spots leftby Apr 2025
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