Status:
COMPLETED
Characterizing and Predicting Drug Effects on Cognition
Lead Sponsor:
University of Minnesota
Conditions:
Cognitive Deficits
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a mild, untoward effect on an essential function such a linguistic behavior, a directly observable product of co...
Detailed Description
The investigators' long-term goal is to enhance clinical strategies and inform drug development in order to maximize the benefits of individual drug therapy while minimizing adverse cognitive/language...
Eligibility Criteria
Inclusion
- Healthy men and women
- Ages 18-50
- Women are post-menopausal or using approved birth control methods
- To control for brain lateralization of language functions, subjects need to have a dominant right hand.
Exclusion
- Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, renal, neurologic, and/or psychiatric disease including suicidality
- Vision or hearing impairments
- Current or a history of drug or alcohol abuse
- living outside of the Twin Cities Metropolitan area.
- The use of concomitant medications known to affect Topiramate (TPM), Lorazepam (LZP), or the use of any concomitant medications that may alter cognitive function
- Prior adverse reaction or prior hypersensitivity to TPM, LZP or related compounds
- A positive pregnancy test (administered to all women before enrollment, and prior to each study session).
- Subjects who have received any investigational drug within the previous 30 days
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01889602
Start Date
July 1 2013
End Date
August 1 2016
Last Update
December 17 2019
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414