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NCT01261260 · ClinicalTrials.gov registry record · Phase 1
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
A Phase 1 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01261260: Completed Phase 1 study, sponsored by Mclean Hospital.
NCT01261260 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01261260, a Phase 1 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Uridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 1 |
What the finished NCT01261260 record still lists
NCT01261260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Uridine is the first listed.
NCT01261260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01261260 about?
NCT01261260 is a clinical study titled "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: 1. Relative to placebo, an...
What is the current status of trial NCT01261260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2006-11. Estimated completion is 2008-08.
What interventions are being tested in trial NCT01261260?
The interventions under investigation include: Uridine (DRUG).
Who is sponsoring clinical trial NCT01261260?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01261260's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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