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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00575848

Run by

North Suffolk Mental Health Association

People needed

16

Starts

2007-12-01

Expected to finish

2008-10-01

Last updated by the study team

2009-11-26

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males aged 18-65 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review
• Clinically stable on a stable dose of antipsychotic medication (any except clozapine or olanzapine) for at least one month, no current active suicidal ideation
• Not treated with investigational medication in the past 30 days
• Competent to provide informed consent

You may not qualify if…

• Diagnosis of dementia, neurodegenerative disease, seizure disorder, current substance abuse or dependence disorders, including alcohol, active within the last 3 months or any Axis I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
• Serious illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease that is not stabilized such that hospitalization for treatment of that illness is likely within the next four months
• Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk
• History of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae
• Uncontrolled hypertension
• Anuretic
• Use of clozapine or olanzapine in the past month
• Subjects who weigh more than 275 lbs
• Subjects who are claustrophobic
• Subjects with a history of electrolyte imbalance
• Subjects who have lost consciousness for 30 minutes or more
• Subjects with lifetime history of stroke
• Subjects with myocardial infarction within the last 6 months
• Those having a pacemaker or a heart arrhythmia
• Source of metal in body incompatible with MRI procedures
• Those who have ever used a dietary glycine supplement

Where it is running

• Brain Imaging Center, McLean Hospital — Belmont, Massachusetts, United States
• Freedom Trail Clinic, Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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