Glycine vs Placebo for the Schizophrenia Prodrome

• ClinicalTrials.gov Identifier: NCT00291226
• Recruitment Status: Completed
• First Posted: February 13, 2006
• Results First Posted: December 29, 2016
• Last Update Posted: April 2, 2020
• Sponsor: Yale University
• Collaborators: Glytech, Inc; National Alliance for Research on Schizophrenia and Depression
• Information provided by (Responsible Party): Yale University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia Prodrome	Drug: Glycine; Drug: Placebo	Phase 2; Phase 3

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Glycine vs Placebo for the Schizophrenia Prodrome
• Study Start Date: March 2006
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Glycine; Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily. Glycine was dispensed under IND 33,515 (DCJ).	Drug: Glycine; Glycine 0.4 g/kg bid
Placebo Comparator: Placebo Group; Placebo was dispensed as a proprietary formulations developed by Glytech, Inc, consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech placebo formulation, consisting of proprietary pre-flavored sugar powders to be dissolved in 8 ounces of water.	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Scale of Prodromal Symptoms Total Score [ Time Frame: Baseline ]
   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.
2. Change in Scale of Prodromal Symptoms Total Score [ Time Frame: Change from Baseline at 8 Weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 35 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

• history of psychosis

Contacts and Locations

Locations

United States, Connecticut

PRIME Clinic

New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Glytech, Inc

National Alliance for Research on Schizophrenia and Depression

Investigators

• Principal Investigator: Scott W Woods, MD; Yale School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00291226
• Other Study ID Numbers: 0502027440
• First Posted: February 13, 2006
• Results First Posted: December 29, 2016
• Last Update Posted: April 2, 2020
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Yale University:

schizophrenia prodrome

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Glycine; Glycine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs