Status:
COMPLETED
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Healthy Male Subjects
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
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 administ...
Detailed Description
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, alon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01261260
Start Date
November 1 2006
End Date
August 1 2008
Last Update
December 16 2010
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478