Glycine vs Placebo for the Schizophrenia Prodrome

Schizophrenia Prodrome Clinical Trial

Official title:

Glycine vs Placebo for the Schizophrenia Prodrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291226
• Other study ID #: 0502027440
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: November 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

Inclusion Criteria:

• meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

• history of psychosis

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia Prodrome

Intervention

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

Locations

Country	Name	City	State
United States	PRIME Clinic	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Glytech, Inc, National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale of Prodromal Symptoms Total Score	Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.	Baseline
Primary	Change in Scale of Prodromal Symptoms Total Score	Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0-6, with 0-2 being the normal range, 3-5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.	Change from Baseline at 8 Weeks