Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

February 14, 2019 updated by: Deborah Yurgelun-Todd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • The Brain Institute, University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • 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 Names:
  • Cognizin Citicoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive performance
Time Frame: 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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deborah Yurgelun-Todd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 24, 2017

Study Completion (Actual)

May 24, 2017

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_49504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurocognitive Improvement

Clinical Trials on Citicoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe