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Glycine Treatment of Prodromal Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00268749
First received: December 20, 2005
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear to be prodromal for schizophrenia in adolescents and young adults.


Condition Intervention Phase
Schizophrenia
 Drug: glycine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glycine Treatment of Prodromal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Glycine
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Scale Of Prodromal Symptoms total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2002
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: glycine
0.8 g/kg/day

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 14-35
  • meets SIPS criteria for psychosis prodrome

Exclusion Criteria:

  • current antipsychotic medication
  • more than 4 weeks of antipsychotic medication lifetime
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268749

Sponsors and Collaborators
Yale University
Stanley Medical Research Institute
Investigators
Principal Investigator: Scott W Woods, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00268749     History of Changes
Other Study ID Numbers: 02T-175
Study First Received: December 20, 2005
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration

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 May 22, 2013