Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
This study is currently recruiting participants.
Verified July 2012 by University of Utah
Sponsor:
Deborah Yurgelun-Todd
Information provided by (Responsible Party):
Deborah Yurgelun-Todd, University of Utah
ClinicalTrials.gov Identifier:
NCT01582113
First received: April 18, 2012
Last updated: July 18, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neurocognitive Improvement |
Drug: Citicoline Other: Microcrystalline Cellulose |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Neurocognitive performance [ Time Frame: 28 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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 Name: Cognizin Citicoline
|
|
Experimental: 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.
|
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 Name: Cognizin Citicoline
|
|
Placebo Comparator: 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.
|
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.
|
Eligibility| Ages Eligible for Study: | 13 Years to 18 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582113
Contacts
| Contact: Allison Locatelli | 801-587-1828 |
Locations
| United States, Utah | |
| The Brain Institute, University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: Deborah Yurgelun-Todd | |
Sponsors and Collaborators
Deborah Yurgelun-Todd
More Information
No publications provided
| Responsible Party: | Deborah Yurgelun-Todd, Professor of Psychiatry, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01582113 History of Changes |
| Other Study ID Numbers: | IRB_49504 |
| Study First Received: | April 18, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cytidine Diphosphate Choline Nootropic Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013