NCT00291226 - Glycine vs Placebo for the Schizophrenia Prodrome | Crick

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

8

Conditions

Schizophrenia Prodrome

Interventions

GlycineDRUG

Glycine 0.4 g/kg bid

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 13 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * meet SIPS criteria for schizophrenia prodrome Exclusion Criteria: * history of psychosis

Locations (1)

PRIME Clinic

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

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.

Time frame: Change from Baseline at 8 Weeks