Healthy Male Subjects Clinical Trial
Official title:
The Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
On the dual basis of findings indicating GABA increases following acute and eight week
SSRI/dopamine agonist administration and those indicating GABA-ergic effects following 14
day pyrimidine administration, the purpose of this study is to assess our following
hypotheses:
1. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase
brain GABA levels in a sample of healthy, unmedicated adult males;
2. Relative to placebo, an oral dose of 1g of uridine BID for seven days will increase NTP
levels in a sample of healthy, unmedicated adult males; and
3. Brain GABA levels will be directly correlated to high energy phosphate levels in this
sample of healthy, unmedicated adult males.
Based on prior MRS studies by our group as well as the work of others, we hypothesize that
oral administration of uridine will actuate an increase in brain gamma-amino butyric acid
(GABA) levels, along with beta-nucleotide triphosphate (ß-NTP) levels, as compared with
baseline. Our aim is to investigate this specific neuropharmacological effect and to
demonstrate the suitability of a novel magnetic resonance spectroscopy protocol in so doing.
Our rationale includes the consideration that the clinical utility of an intervention
demonstrably effective in elevating brain GABA and high energy phosphate levels is broad,
since lowered GABA and bioenergetic states are associated with a plurality of affective,
anxiety, and substance use disorders.
On the dual basis of findings indicating GABA increases following acute and eight week
SSRI/dopamine agonist administration and those noting GABA-ergic effects of 14 day
pyrimidine administration, we hypothesize that an oral dose of 2g of uridine per day for
seven days will increase brain GABA levels in a sample of healthy, unmedicated adult males.
We also hypothesize that this 2g dose of uridine per day for 7 days will increase ß-NTP
levels and, further, that the increase in GABA and high energy phosphate levels will be
correlated. Of note, the phosphorylation of glutamic acid decarboxylase by ATP significantly
increased the activity of this enzyme, which is reponsable for the synthesis of GABA. 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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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