Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014