Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

Early Phase 1

Completed

• Conditions: Neurocognitive Improvement
• Interventions: Other: Microcrystalline Cellulose; Drug: Citicoline

• Registration Number: NCT01582113
• Lead Sponsor: Deborah Yurgelun-Todd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-06
• Primary Completion: 2017-05-24
• Study Completion: 2017-05-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Microcrystalline Cellulose	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.
High Dose Citicoline	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.
Low Dose Citicoline	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.

Primary Outcome Measures

Name	Time	Method
Neurocognitive performance	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.

Trial Locations

Locations (1)

The Brain Institute, University of Utah; 🇺🇸 Salt Lake City, Utah, United States