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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2006

Last Updated Date

January 13, 2010

Start Date ^ICMJE

March 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Scale of Prodromal Symptoms total score

Change History

Complete list of historical versions of study NCT00291226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Glycine vs Placebo for the Schizophrenia Prodrome

Official Title ^ICMJE

Glycine vs Placebo for the Schizophrenia Prodrome

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia Prodrome

Intervention ^ICMJE

Drug: Glycine
Glycine 0.4 g/kg bid
Drug: Placebo
Placebo

Study Arm (s)

Experimental: 1
Glycine

Intervention: Drug: Glycine
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

history of psychosis

Gender

Both

Ages

13 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00291226

Other Study ID Numbers ^ICMJE

Glytech, NARSAD Distinguished 2005

Has Data Monitoring Committee

Yes

Responsible Party

Scott Woods, Yale University School of Medicine

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Glytech, Inc
National Alliance for Research on Schizophrenia and Depression

Investigators ^ICMJE

Principal Investigator:

Scott W Woods, MD

Yale School of Medicine

Information Provided By

Yale University

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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