Cognizin Citicoline Dosing in a Healthy Adolescent Male Population

Deborah Yurgelun-Todd

Status and phase: Completed; Early Phase 1

Conditions: Neurocognitive Improvement

Treatments: Other: Microcrystalline Cellulose; Drug: Citicoline

Study type: Interventional

Funder types: Other

Identifiers

NCT01582113

IRB_49504

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: Male

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 3 patient groups, including a placebo group

High Dose Citicoline

Experimental group

Description:

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.

Treatment:

Drug: Citicoline

Low Dose Citicoline

Experimental group

Description:

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.

Treatment:

Drug: Citicoline

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Microcrystalline Cellulose