CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Glycine administrationdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01610011
NCT01610011N/ACompleted

Acute Glycine Pharmacodynamic Study

Mclean Hospital·interventional·Posted Jun 1, 2012·Updated Oct 27, 2015

In Brief

A clinical study evaluating Glycine administration for Schizophrenia and Psychotic Disorders. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2012
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.1 years ago

Interventions

Glycine administrationdietary

Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.