Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
NCT ID: NCT01582113
Last Updated: 2019-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
84 participants
INTERVENTIONAL
2012-06-30
2017-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High Dose Citicoline
At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of 500 mg of citicoline, of which they will be instructed to take 500 mg daily. This will be done in a double-blind, randomized fashion.
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.
Low Dose Citicoline
At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of 250 mg of citicoline, of which they will be instructed to take 250 mg daily. This will be done in a double-blind, randomized fashion.
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.
Placebo
At visit 1 and again at visit 2, participants assigned to the placebo group will be given 14-day supplies of placebo to be taken daily throughout the study period. This will be done in a double-blind, randomized fashion.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 13-18 years old
* No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial
Exclusion Criteria
* Use of any psychotropic medication
13 Years
18 Years
MALE
Yes
Sponsors
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Deborah Yurgelun-Todd
OTHER
Responsible Party
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Deborah Yurgelun-Todd
Professor of Psychiatry
Locations
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The Brain Institute, University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_49504
Identifier Type: -
Identifier Source: org_study_id
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