Glycine Treatment of Prodromal Symptoms

Schizophrenia Clinical Trial

Official title:

Glycine Treatment of Prodromal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268749
• Other study ID #: 02T-175
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: March 28, 2012
• Start date: July 2002
• Est. completion date: November 2004

Study information

• Verified date: March 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 35 Years

Eligibility

Inclusion Criteria:

• age 14-35

• meets SIPS criteria for psychosis prodrome

Exclusion Criteria:

• current antipsychotic medication

• more than 4 weeks of antipsychotic medication lifetime

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prodromal Symptoms
• Schizophrenia

Intervention

Drug:
• glycine
0.8 g/kg/day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Stanley Medical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale Of Prodromal Symptoms total score		8 weeks	No