NCT01582113

Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Deborah Yurgelun-Todd · Academic / Other
• Sex: Male
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

Summary

To determine the functional effects of Citicoline, a natural supplement, when administered for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The investigators hypothesize that citicoline will provide cognitive benefits to this population after 28 days of supplementation.

Conditions

• Neurocognitive Improvement

Interventions

Type	Name	Description
DRUG	Citicoline	Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 500 mg or 250 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.
OTHER	Microcrystalline Cellulose	Microcrystalline Cellulose will be the placebo administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2012-04-20
• Last updated: 2019-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study