Glycine vs Placebo for the Schizophrenia Prodrome

This study is currently recruiting participants.

Verified by Yale University, March 2008

Sponsors and Collaborators:	Yale University Glytech, Inc National Alliance for Research on Schizophrenia and Depression
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00291226

Purpose

Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

Condition	Intervention	Phase
Schizophrenia Prodrome	Drug: Glycine Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Glycine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Glycine vs Placebo for the Schizophrenia Prodrome

Further study details as provided by Yale University:

Primary Outcome Measures:

Scale of Prodromal Symptoms total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	March 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Glycine	Drug: Glycine Glycine 0.4 g/kg bid
2: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	13 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

history of psychosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291226

Contacts

Contact: Barbara Walsh, PhD	203 974-7053	barbara.walsh@yale.edu
Contact: John Saksa, PsyD	203 974 7043	john.saksa@yale.edu

Locations

United States, Connecticut
PRIME Clinic	Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Scott Woods, MD

Sponsors and Collaborators

Yale University

Glytech, Inc

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Scott W Woods, MD

Yale School of Medicine

More Information

Responsible Party:	Yale University School of Medicine ( Scott Woods )
Study ID Numbers:	Glytech, NARSAD Distinguished 2005
Study First Received:	February 10, 2006
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00291226
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

schizophrenia prodrome

Study placed in the following topic categories:

Schizophrenia
Glycine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Glycine Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009