Neurocognitive ImprovementEarly Phase 1NCT01582113
Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
A Early Phase 1 study testing Citicoline and Microcrystalline Cellulose in people with Neurocognitive Improvement, run by Deborah Yurgelun-Todd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Improvement
- What is being tested?
- Citicoline and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 24 May 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male
- Age 13-18 years old
- No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial
Who cannot join
- Head injury with LOC > 5 minutes
- Use of any psychotropic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Brain Institute, University of Utah
Salt Lake City, Utah, 84108
About this study
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
- Being tested
- Citicoline, Microcrystalline Cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
Also called 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.
Microcrystalline CelluloseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJun 2012
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Yurgelun-Todd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Yurgelun-Todd, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582113
- Sponsor's protocol ID
- IRB_49504
- Status last verified
- Feb 2019
- First submitted
- 18 Apr 2012
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
- ClinicalTrials.gov ID
- NCT01582113
- Acronym / sponsor ID
- IRB_49504
- Conditions
- Neurocognitive Improvement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Deborah Yurgelun-ToddUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Citicoline | Experimental | Drug: CiticolineAt 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 | Experimental | Drug: CiticolineAt 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. |
| Placebo | Placebo comparator | Other: Microcrystalline CelluloseAt 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male
- Age 13-18 years old
- No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial
Key exclusion criteria (2 listed)
- Head injury with LOC > 5 minutes
- Use of any psychotropic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineAlso: Cognizin CiticolineParticipants 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. | Drug | High Dose Citicoline, Low Dose Citicoline |
| Microcrystalline CelluloseMicrocrystalline 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. | Other | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Citicoline and Microcrystalline Cellulose in people with Neurocognitive Improvement, run by Deborah Yurgelun-Todd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive performance (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.