Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

NCT01582113 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB_49504
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Improvement

Outcome Measures

Primary Outcomes (1)

• Neurocognitive performance

  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

Study Arms (3)

High Dose Citicoline

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.

Drug: Citicoline

Low Dose Citicoline

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.

Drug: Citicoline

Placebo

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.

Other: Microcrystalline Cellulose

Interventions

Citicoline DRUG

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.

Also known as: Cognizin Citicoline

High Dose Citicoline; Low Dose Citicoline

Microcrystalline Cellulose OTHER

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.

Placebo

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male
• Age 13-18 years old
• No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial

You may not qualify if:

• Head injury with LOC \> 5 minutes
• Use of any psychotropic medication

Sponsors & Collaborators

• Deborah Yurgelun-Todd: lead

Study Sites (1)

The Brain Institute, University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Cytidine Diphosphate Choline; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: June 1, 2012
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

US (1)