Glycine vs Placebo for the Schizophrenia Prodrome

This study has been completed.
Sponsor:
Collaborators:
Glytech, Inc
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00291226
First received: February 10, 2006
Last updated: January 13, 2010
Last verified: January 2010
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glycine vs Placebo for the Schizophrenia Prodrome

Resource links provided by NLM:


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 ]

Enrollment: 8
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glycine
Drug: Glycine
Glycine 0.4 g/kg bid
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
PRIME Clinic
New Haven, Connecticut, United States, 06519
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

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Woods, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00291226     History of Changes
Other Study ID Numbers: Glytech, NARSAD Distinguished 2005
Study First Received: February 10, 2006
Last Updated: January 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
schizophrenia prodrome

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014