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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: National Institute of Mental Health (NIMH)

Criteria

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.