Healthy Male Subjects Clinical Trial
— Uridine-GABAOfficial title:
The Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
Verified date | December 2010 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male - Age range of 18-60 years - BMI between 18.5 and 28 - Medication-free - Capable of providing informed consent - Non- smoking for a minimum of one year Exclusion Criteria: - Meets DSM-IV criteria for any Axis I disorder (past or present) - Global assessment of functioning (DSM IV TR) less than 50 - Age less than 18 or greater than 60 - BMI lower than 18.5 or higher than 28 - Any history of Alcohol or substance dependence or abuse according to DSM-IV criteria (except for caffeine dependence) - Any medical condition which in the opinion of the investigator may have an effect on mood symptoms - Any individual who has a current mood disturbance (as defined by DSM-IV-R criteria) - Use of cigarettes or other nicotine-containing products - Allergy or other contraindication to uridine - Individuals unable to comply with instructions or procedures of study - History of significant head trauma - Claustrophobia or other contraindication to MRI (e.g., pacemaker, metal fragments) - Any illicit substance use in the past thirty days - Any past treatment for substance abuse - Any past hospitalization for mental illness. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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