Diminished P50 Sensory Gating, Schizophrenia
Conditions
Brief 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. 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.
Interventions
DRUGphosphatidylcholine supplementation
phosphatidylcholine concentrate 700 mg twice per day
DRUGplacebo
placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 7 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of P50 auditory sensory gating | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 4 weeks and 8 weeks after initiation of intervention | Percentage of infants with adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of planned dietary supplement | 8 weeks | Percentage of planned dietary supplement given to the infant |
| Change in serum choline, betaine, and dimethylglycine levels | Randomization and 8 weeks | — |
Countries
United States
Outcome results
None listed