Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Citicoline | Experimental | 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. |
|
| Low Dose Citicoline | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive performance | 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. | 28 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brain Institute, University of Utah | Salt Lake City | Utah | 84108 | United States |
Not provided
| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Microcrystalline Cellulose | Other | 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. |
|
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |