Healthy Male SubjectsPhase 1Uridine-GABANCT01261260
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
A Phase 1 study testing Uridine in people with Healthy Male Subjects, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- Uridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
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:
- 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;
- 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
- Brain GABA levels will be directly correlated to high energy phosphate levels in this sample of healthy, unmedicated adult males.
Read the 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, along with beta-nucleotide triphosphate (ß-NTP) levels, as compared with baseline. Our aim is to investigate this specific neuropharmacological effect and to demonstrate the suitability of a novel magnetic resonance spectroscopy protocol in so doing. Our rationale includes the consideration that the clinical utility of an intervention demonstrably effective in elevating brain GABA and high energy phosphate levels is broad, since lowered GABA and bioenergetic states are associated with a plurality of affective, anxiety, and substance use disorders.
On the dual basis of findings indicating GABA increases following acute and eight week SSRI/dopamine agonist administration and those noting GABA-ergic effects of 14 day pyrimidine administration, we hypothesize that an oral dose of 2g of uridine per day for seven days will increase brain GABA levels in a sample of healthy, unmedicated adult males. We also hypothesize that this 2g dose of uridine per day for 7 days will increase ß-NTP levels and, further, that the increase in GABA and high energy phosphate levels will be correlated. Of note, the phosphorylation of glutamic acid decarboxylase by ATP significantly increased the activity of this enzyme, which is reponsable for the synthesis of GABA. 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.
- Conditions
- Healthy Male Subjects
- Being tested
- Uridine
- Keywords
- uridine, gamma-amino butyric acid, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Proton Echo-Planar Spectroscopic Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UridineDrug
1 gram tablets BID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Uridine | Placebo comparator | 1g BID Receives: Drug: Uridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Perry F Renshaw, MD PhD, Principal investigator, The Brain Institute, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261260
- Sponsor's protocol ID
- 2005-P-002083-McLean
- Other IDs
- 2R01MH058681-04A2
- Acronym
- Uridine-GABA
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01261260
- Acronym / sponsor ID
- Uridine-GABA / 2005-P-002083-McLean
- Conditions
- Healthy Male Subjects
- Keywords
- uridine, gamma-amino butyric acid, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Proton Echo-Planar Spectroscopic Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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
- Brain GABA levels will be directly correlated to high energy phosphate levels in this sample of healthy, unmedicated adult males.
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, along with beta-nucleotide triphosphate (ß-NTP) levels, as compared with baseline. Our aim is to investigate this specific neuropharmacological effect and to demonstrate the suitability of a novel magnetic resonance spectroscopy protocol in so doing. Our rationale includes the consideration that the clinical utility of an intervention demonstrably effective in elevating brain GABA and high energy phosphate levels is broad, since lowered GABA and bioenergetic states are associated with a plurality of affective, anxiety, and substance use disorders.
On the dual basis of findings indicating GABA increases following acute and eight week SSRI/dopamine agonist administration and those noting GABA-ergic effects of 14 day pyrimidine administration, we hypothesize that an oral dose of 2g of uridine per day for seven days will increase brain GABA levels in a sample of healthy, unmedicated adult males. We also hypothesize that this 2g dose of uridine per day for 7 days will increase ß-NTP levels and, further, that the increase in GABA and high energy phosphate levels will be correlated. Of note, the phosphorylation of glutamic acid decarboxylase by ATP significantly increased the activity of this enzyme, which is reponsable for the synthesis of GABA. 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uridine | Placebo comparator | Drug: Uridine1g BID |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Age range of 18-60 years
- BMI between 18.5 and 28
- Medication-free
- Capable of providing informed consent
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uridine1 gram tablets BID for 7 days | Drug | Uridine |
Primary outcome
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
Time frame: after 7 days of treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
Related trials for Healthy Male Subjects
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Not yet recruitingPhase 1
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
Health Adult Subjects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perry F Renshaw, MD PhD principal investigator
The Brain Institute, University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Uridine in people with Healthy Male Subjects, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: after 7 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2010; AzTrials last refreshed its copy on 8 Nov 2026.