N/A N=21 Basic Science

Acute Glycine Pharmacodynamic Study

Schizophrenia · Psychotic Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01610011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg). — 393; 677 Percent brain glycine/creatine increase

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Glycine administration (Dietary_supplement)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mclean Hospital
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg).	393; 677	—

Summary

The purpose of this study is to use proton magnetic resonance spectroscopy (MRS) at 4 Tesla to measure brain glycine levels noninvasively at baseline and for 2 hours after a single oral dose of a concentrated glycine-containing beverage, and to compare MRS glycine measurements to glycine blood levels in samples obtained after each MRS spectrum. The investigators hypothesize that they will observe a high correlation between the magnitude increases in brain and plasma glycine levels over this time frame. The investigators also hypothesize that we will observe large intersubject variability in glycine uptake rates into brain and blood. The investigators also hypothesize that subjects with a glycine decarboxylase (GLDC) mutation (triplication) will have lower baseline plasma and brain glycine levels and will experience smaller brain and plasma glycine increases after glycine consumption than controls or family members without the GLDC mutation.

Eligibility Criteria

Inclusion Criteria

Healthy Adult males
Members of a family known to the research team with some members possessing a GLDC genetic mutation

Exclusion Criteria

Contraindications to magnetic resonance scanning including metallic surgical implants or claustrophobia
History of head injury with loss of consciousness > 5 minutes
Brain structural abnormalities identified on MRI scan
Known sensitivity or allergy to glycine
History of taking glycine or other dietary supplements
Healthy controls: history of psychiatric or substance use disorders; individuals taking prescription medications
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01610011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.