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

Completed · Phase 1

Conditions studied: Healthy Male Subjects

In brief

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.

Key facts

Study ID

NCT01261260

Run by

Mclean Hospital

People needed

33

Starts

2006-11-01

Expected to finish

2008-08-01

Last updated by the study team

2010-12-16

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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