NCT00268749

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Jul 2002

Typical duration for phase_2 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

2.3 years

First QC Date

December 20, 2005

Last Update Submit

March 28, 2012

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Scale Of Prodromal Symptoms total score

    8 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: glycine

Interventions

glycineDRUG

0.8 g/kg/day

1

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • current antipsychotic medication
  • more than 4 weeks of antipsychotic medication lifetime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Woods SW, Walsh BC, Hawkins KA, Miller TJ, Saksa JR, D'Souza DC, Pearlson GD, Javitt DC, McGlashan TH, Krystal JH. Glycine treatment of the risk syndrome for psychosis: report of two pilot studies. Eur Neuropsychopharmacol. 2013 Aug;23(8):931-40. doi: 10.1016/j.euroneuro.2012.09.008. Epub 2012 Oct 22.

    PMID: 23089076DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Glycine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Scott W Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

July 1, 2002

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

March 29, 2012

Record last verified: 2012-03