Glycine vs Placebo for the Schizophrenia Prodrome

NCT00291226 | Completed Phase 2 Results DMC

• 1 other identifier: 0502027440
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Prodrome

Keywords

schizophrenia prodrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Glycine

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Glycine DRUG

Glycine 0.4 g/kg bid

Glycine

Placebo DRUG

Placebo

Placebo Group

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• meet SIPS criteria for schizophrenia prodrome

You may not qualify if:

• history of psychosis

Sponsors & Collaborators

• Yale University: lead
• Glytech, Inc: collaborator
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

PRIME Clinic

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 23089076 DERIVED

MeSH Terms

Interventions

Glycine

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Scott W. Woods, MD
• Organization: Yale University School of Medicine

scott.woods@yale.edu

203-974-7038

Study Officials

• Scott W Woods, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 2, 2020
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)