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Glycine Treatment of Prodromal Symptoms

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
glycine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age 14-35 meets SIPS criteria for psychosis prodrome Exclusion Criteria: current antipsychotic medication more than 4 weeks of antipsychotic medication lifetime

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Scale Of Prodromal Symptoms total score

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2005
    Last Updated
    March 28, 2012
    Sponsor
    Yale University
    Collaborators
    Stanley Medical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00268749
    Brief Title
    Glycine Treatment of Prodromal Symptoms
    Official Title
    Glycine Treatment of Prodromal Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    Stanley Medical Research Institute

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    glycine
    Intervention Description
    0.8 g/kg/day
    Primary Outcome Measure Information:
    Title
    Scale Of Prodromal Symptoms total score
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott W Woods, MD
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23089076
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Glycine Treatment of Prodromal Symptoms

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