Study of the Effects of Glycine on Symptoms and Memory in Patients With Schizophrenia

Summary

The goal of this project is to understand whether glycine is helpful for improving some symptoms of schizophrenia such as low motivation, loss of interest, and social isolation. In addition, the investigators want to find out if glycine improves memory.

This project involves a three-and-a-half month trial of glycine or placebo. A placebo looks exactly like the study drug, but it contains no active drug. Glycine is a naturally occurring substance that is a part of some of the proteins in your body. Glycine has not been approved by the FDA (Food and Drug Administration) for the treatment of schizophrenia. However, the FDA allows it to be used in research studies.

Related Study at McLean Hospital: If you would like to participate in this study of glycine versus placebo at the Freedom Trail Clinic, the investigators will ask you if you would also like to participate in a related study at McLean Hospital. The study at McLean Hospital will look at the effects of glycine and placebo on levels of glycine in the brain. The study will use magnetic resonance spectroscopy to measure brain glycine levels. The magnetic resonance (MR) scanner looks like a large cylinder with a tube running down the center. You will be asked to lie down on your back on a foam-padded table and place your head into a special holder. The table will slide you inside the "hole" of the scanner. Soft foam rubber sponges may be placed on both sides of your head for comfort and to help keep your head from moving. Because the scanner contains a strong magnet, you will be asked to remove all metal objects from your person including, but not limited to: watches, rings, necklaces, bracelets, earrings and other body piercings, belts, loose change, wallet (with credit cards), items of clothing containing magnetic materials (for example, underwire bras, certain types of zippers), and shoes. These items will be secured in a safe place until your scan is completed. You will be able to remain in your street clothes. The investigators will ask you if study staff from McLean Hospital can contact you to tell you more about the study. You may refuse to be contacted by McLean Hospital. However, if you do not participate in the study at McLean, you are not eligible for the study here at the Freedom Trail Clinic.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

DIETARY_SUPPLEMENT

Glycine

Subjects will consume glycine twice daily, once with breakfast and once with dinner. The medication is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.

DIETARY_SUPPLEMENT

Placebo

Subjects will consume placebo twice daily, once with breakfast and once with dinner. The placebo is in liquid form. They will be instructed to refrigerate the liquid until the time that they take it. Subjects start by taking 10g per day for the first 2 days. Starting on the 3rd day, subjects take 0.2g/kg (15g for a 75kg adult) per day, and increase dosage by 0.2g/kg every two days, until they reach 0.8g/kg per day, which they take for the remainder of the 6-week period.

Sponsors & Collaborators

• Mclean Hospital

  collaborator OTHER

• National Alliance for Research on Schizophrenia and Depression

  collaborator OTHER

• North Suffolk Mental Health Association

  lead OTHER

Principal Investigators

• A. Eden Evins, M.D., M.P.H. · Massachusetts General Hospital

• Andrew Prescot, Ph.D. · Mclean Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2008-10-31

Completion

2008-10-31

Countries

• United States

Study Locations