A Study of the Effects of Sarcosine on Symptoms and Brain Glycine Levels in People With Schizophrenia - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Massachusetts General Hospital
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00538070

Sponsor:

National Institute on Drug Abuse (NIDA)

Collaborator:

Massachusetts General Hospital

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00538070

Purpose

The purpose of this study is to evaluate the effect of a dietary supplement on the concentration of a small protein called glycine that is found in the brain in people with schizophrenia. The dietary supplement is called sarcosine. We want to see how taking sarcosine for 6 weeks affects levels of glycine in the brain. Sarcosine and glycine are both part of the proteins that occur naturally in our bodies. The study involves 6 weeks of taking sarcosine or placebo added to your regular drugs. A placebo looks exactly like sarcosine, but does not contain active drug. In this study, the placebo will not contain any dietary supplement.

Sarcosine is a dietary supplement which is not FDA approved for treatment of any specific medical or nutritional use.

It is thought that increasing concentrations of the protein, glycine, in brain will improve some symptoms of schizophrenia. This study tests whether taking sarcosine will increase brain concentration of glycine and whether this is correlated with any change in symptoms.

We are asking you to take part in this study because you have been diagnosed with schizophrenia or schizoaffective disorder and because you smoke cigarettes.

If you decide to take part in this study, we will use a magnetic resonance brain scan (MRS) to measure the glycine levels in your brain. We hope that this study will help us to better understand the brains of people with schizophrenia.

The brain scans will be done at McLean Hospital in Belmont, MA. We will provide transportation to and from McLean.

Sarcosine is a naturally occurring substance. It is found in muscles and other body tissues. It is also found in food such as egg yolk, ham, turkey, and vegetables. Sarcosine has been studied in 2 other studies that involved a total of 38 people with schizophrenia who took sarcosine. It was shown to improve some symptoms of schizophrenia. No study has looked at whether sarcosine changes brain glycine levels. We expect that about 70 people will enroll in this study at the Massachusetts General Hospital (MGH).

This is an early study, called a 'pilot' study that is being conducted to learn how the compound sarcosine affects brain glycine levels.

Condition	Intervention
Schizophrenia	Dietary Supplement: Sarcosine

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Glycine Transport Inhibition on Brain Glycine Concentration

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Schizophrenia

Drug Information available for: Glycine Sarcosine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Increases in brain glycine concentration as measured by magnetic resonance spectroscopy [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	August 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo You will receive two grams of placebo per day. You will take two 500 mg placebo capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.	Dietary Supplement: Sarcosine You will receive two grams of sarcosine or placebo per day. Each capsule will contain 500 mg of sarcosine or placebo. You will take two capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study. Other Name: glycine transport inhibitor
Experimental: Sarcosine You will receive two grams of sarcosine per day. You will take two 500 mg capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.	Dietary Supplement: Sarcosine You will receive two grams of sarcosine or placebo per day. Each capsule will contain 500 mg of sarcosine or placebo. You will take two capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study. Other Name: glycine transport inhibitor

Arms

Assigned Interventions

Placebo Comparator: Placebo

You will receive two grams of placebo per day. You will take two 500 mg placebo capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.

Dietary Supplement: Sarcosine

You will receive two grams of sarcosine or placebo per day. Each capsule will contain 500 mg of sarcosine or placebo. You will take two capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.

Other Name: glycine transport inhibitor

Experimental: Sarcosine

You will receive two grams of sarcosine per day. You will take two 500 mg capsules twice per day, once in the morning and once in the evening, every day for six weeks. You can take the pills with or without food. You should continue to take all your other medications throughout the study.

Dietary Supplement: Sarcosine

Other Name: glycine transport inhibitor

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Women and men 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 for at least one month, no current active suicidal ideation.
Competent to provide informed consent.
Women of childbearing age must have a negative pregnancy test at screening and agree to use an approved form of contraception throughout the study.
Current smokers of at least 10 cigarettes per day.
Screening labs within normal limits for age and gender except for liver function tests as specified below.

EXCLUSION CRITERIA:

Diagnosis of bipolar disorder, dementia, neurodegenerative disease, or other organic mental disorder.
History of seizure disorder or CNS tumor.
Liver function tests elevated over twice normal.
Bulimia, or major depressive disorder within the last 6 months.
Life-threatening arrhythmia, cerebro-vascular, or cardiovascular event within 6 months. Current serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months. Lifetime history of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
Use of investigational medication within 30 days of enrollment.
Use of clozapine.
Substance use disorder other than nicotine or caffeine in the last 6 months (by self report and salivary drug and alcohol screen).
Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk.
People with implanted metal devices that would make participation in MRI/MRS procedures unsafe.
Claustrophobia
Weight >275 lbs.
Past use of dietary glycine or sarcosine supplement
History of brain or heart surgery or stroke
Myocardial Infarction in the past 6 months

Contact: Alice Coakley, B.A.	617-912-7863	acoakley1@partners.org
Contact: Priscilla Sinclair, B.A.	617-912-7829	psinclair1@partners.org

United States, Massachusetts
McLean Hospital, Brain Imaging Center	Recruiting
Belmont, Massachusetts, United States, 02478
Principal Investigator: Marc J. Kaufman, Ph.D.
Freedom Trail Clinic, Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alice Coakley, B.A. 617-912-7863 acoakley1@partners.org
Contact: Priscilla Sinclair, B.A. (617) 912-7829 psinclair1@partners.org
Principal Investigator: A. Eden Evins, M.D., M.P.H.

Principal Investigator:	A. Eden Evins, M.D., M.P.H.	Massachusetts General Hospital
Principal Investigator:	Marc Kaufman, Ph.D.	Mclean Hospital

Responsible Party:	A. Eden Evins, M.D., MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00538070 History of Changes
Other Study ID Numbers:	1 RO1 DA 022276-01, #2007-P-000416/1, R01DA022276, DPMC
Study First Received:	October 1, 2007
Last Updated:	November 24, 2009
Health Authority:	United States: Institutional Review Board; United States: Federal Government