Neurocognitive Improvement
Conditions
Brief 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.
Interventions
DRUGCiticoline
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.
OTHERMicrocrystalline 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.
Sponsors
Deborah Yurgelun-Todd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Age 13-18 years old * No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial
Exclusion criteria
* Head injury with LOC \> 5 minutes * Use of any psychotropic medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive performance | 28 days | Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of citicoline will improve neurocognitive performance in male adolescents. |
Countries
United States
Outcome results
None listed