SchizophreniaPhase 1/2NCT01905605
Phosphatidylcholine Supplementation in Infants
A Phase 1/2 study testing phosphatidylcholine supplementation in people with Schizophrenia and Diminished P50 Sensory Gating, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. Read more about this study
- Who is it for?
- Ages 1 week to 7 weeksHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Diminished P50 Sensory Gating
- What is being tested?
- phosphatidylcholine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2017
- Phase
- Phase 1/2
- 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 1 week to 7 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
- Diminished P50 sensory gating (ratio greater than or equal to 0.50)
Who cannot join
- No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
- Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.
- Conditions
- Schizophrenia, Diminished P50 Sensory Gating
- Being tested
- phosphatidylcholine supplementation, placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphatidylcholine supplementationDrug
Also called Phosphatidylcholine, phosphatidylcholine concentrate
phosphatidylcholine concentrate 700 mg twice per day
placeboDrug
Also called Corn Oil
placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day
| Study group | Role | What they receive |
|---|---|---|
| phosphatidylcholine supplementation | Experimental | Phosphatidylcholine supplementation to be administered BID for 8 weeks Receives: Drug: phosphatidylcholine supplementation |
| placebo supplementation | Placebo comparator | Placebo to be administered BID for 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of P50 auditory sensory gating
In an auditory evoked potential paradigm while in active sleep (the infant equivalent of rapid eye movement sleep) with two identical sounds presented 500 ms apart, the ratio of the amplitude of the P50 response to the second sound divided by the amplitude of the P50 response to the first sound.
Measured: 8 weeks post initiation of treatment
Secondary outcomes (1)
Incidence of adverse events
Percentage of infants with adverse events
Measured: 4 weeks and 8 weeks after initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startSep 2013 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Funding not secured. IRB approval has been withdrawn as of January 2017.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905605
- Sponsor's protocol ID
- 13-2182
- Status last verified
- Aug 2020
- First submitted
- 18 Jul 2013
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
- ClinicalTrials.gov ID
- NCT01905605
- Acronym / sponsor ID
- 13-2182
- Conditions
- Schizophrenia, Diminished P50 Sensory Gating
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not secured. IRB approval has been withdrawn as of January 2017.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2013 (estimated)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jul 2013 (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.
Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phosphatidylcholine supplementation | Experimental | Drug: phosphatidylcholine supplementationPhosphatidylcholine supplementation to be administered BID for 8 weeks |
| placebo supplementation | Placebo comparator | Drug: placeboPlacebo to be administered BID for 8 weeks |
Who may qualify
- Ages
- 1 week to 7 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
- Diminished P50 sensory gating (ratio greater than or equal to 0.50)
Key exclusion criteria (2 listed)
- No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
- Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use
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 |
|---|---|---|
| phosphatidylcholine supplementationAlso: Phosphatidylcholine, phosphatidylcholine concentratephosphatidylcholine concentrate 700 mg twice per day | Drug | phosphatidylcholine supplementation |
| placeboAlso: Corn Oilplacebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day | Drug | placebo supplementation |
Primary outcome
Ratio of P50 auditory sensory gating
Time frame: 8 weeks post initiation of treatment
In an auditory evoked potential paradigm while in active sleep (the infant equivalent of rapid eye movement sleep) with two identical sounds presented 500 ms apart, the ratio of the amplitude of the P50 response to the second sound divided by the amplitude of the P50 response to the first sound.
1 secondary outcome
Incidence of adverse events
Time frame: 4 weeks and 8 weeks after initiation of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- University of Colorado School of Medicine Developmental Psychiatry Research LabLink provided by the sponsor.
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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.
Robert Freedman, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing phosphatidylcholine supplementation in people with Schizophrenia and Diminished P50 Sensory Gating, run by University of Colorado, Denver 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 2 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Ratio of P50 auditory sensory gating (time frame: 8 weeks post initiation of treatment). 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 2 Sep 2020.