Clinical TrialID 4973

Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers

NCT01261260

Healthy Male Subjects

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Record Fields

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Clinical Trial Id
4973
Evidence Id
4973
Core Evidence Id
4973
Source Clinical Trial Id
4953
Herb2 Clinical Trial Id
HBCT004953
Nct Id
NCT01261260
Title
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Healthy Male Subjects
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
Intervention
DRUG: Uridine
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Gender
Male
Age
Adult
Enrollment
33
Outcome Measure
Using MRI and MRS, after uridine administration an increase in brain GABA and NTP levels will be seen and increases in GABA and NTP will be correlated, This choice of time period will allow a determination of time course to efficacy between the acute and extended ranges, and further, because therapeutic dosage levels of uridine have yet to be established, in this and future studies we hope to determine the optimal dosage at which uridine increases brain GABA and ß-NTP levels., after 7 days of treatment
Sponsor Collaborator
Mclean Hospital|National Institute of Mental Health (NIMH)
Funded By
OTHER
Location
McLean Hospital, Belmont, Massachusetts, 02478, United States
Other Id
2005-P-002083-McLean|2R01MH058681-04A2
Start Date
2006-11
Primary Completion Date
2008-08
Completion Date
2008-08
First Posted
2010-12-16
Results First Posted
Last Update Posted
2010-12-16
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01261260
Title Cn
Title En
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
Bilingual Status
semi_complete