Overview

This trial is active, not recruiting.

Condition neurocognitive improvement
Treatments citicoline, microcrystalline cellulose
Sponsor Deborah Yurgelun-Todd
Start date June 2012
End date December 2016
Trial size 84 participants
Trial identifier NCT01582113, IRB_49504

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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.
citicoline Cognizin 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.
(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.
citicoline Cognizin 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.
(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.
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.

Primary Outcomes

Measure
Neurocognitive performance
time frame: 28 days

Eligibility Criteria

Male participants from 13 years up to 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Utah.