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

NCT01261260 | Completed Phase 1

• 2 other identifiers: 2005-P-002083-McLean2R01MH058681-04A2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 administration, the purpose of this study is to assess our following hypotheses:

1. 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. 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. 3.Brain GABA levels will be directly correlated to high energy phosphate levels in this sample of healthy, unmedicated adult males.

Conditions

Healthy Male Subjects

Keywords

uridine; gamma-amino butyric acid; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy; Proton Echo-Planar Spectroscopic Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Uridine

PLACEBO COMPARATOR

1g BID

Drug: Uridine

Interventions

Uridine DRUG

1 gram tablets BID for 7 days

Uridine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Interventions

Uridine

Intervention Hierarchy (Ancestors)

Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Perry F Renshaw, MD PhD

  The Brain Institute, University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 16, 2010
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

US (1)