| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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Schizophrenia |
| Purpose: |
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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.
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| Study summary: |
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WHAT WILL HAPPEN IN THIS RESEARCH STUDY?
The study is a randomized, double-blind, and placebo-controlled study. There are two study
drug plans. You will be assigned to one of the two plans.
"Randomization" means you will be assigned to one of the study drug plans by chance (like
flipping a coin). "Double blind" means that neither you nor the study doctors and members of
the study staff will know to which study plan you have been assigned. However, if it
becomes necessary to find out whether you are taking sarcosine or placebo, the study doctor
can find this out quickly. You will have an equal chance of getting the sarcosine or the
placebo. We use placebos in research studies to learn if the effects seen in research
subjects are truly from the study drug. The "randomization" (study drug assignment) will
take place at the first study visit.
If you agree to take part in this study and you are sexually active, you must use birth
control. For females, acceptable forms of birth control include diaphragm, copper
intra-uterine device (IUD), female vaginal condom, or having a male sexual partner wear a
condom. If you suspect that you have become pregnant during the course of this study, please
stop the study drug immediately and contact the study staff right away.
If the results from the Screening Visit indicate that you are qualified, you will be asked
to take part in the study. If you qualify, we will arrange a time and a date for you to
come for 7 study visits. You will start taking the study drug after the first of these 7
visits (which we call the Initial Visit). On 2 of these study visits (including the Initial
Visit), we will also ask you to travel to McLean Hospital for a brain scan.
STUDY VISITS AT THE FREEDOM TRAIL CLINIC
After screening, we will ask you to come for 9 study visits. The initial visit includes
questionnaires, an interview, tests of memory and concentration, and a brain scan at McLean
Hospital. There will be one other visit that will be almost identical to this initial visit.
These will take place 6 weeks after the initial visit. There will also be shorter visits
that will take place 1, 2, 3, 4, 5, and 6 weeks after you start taking the study drug.
Though we do not ask that you change your smoking habits while taking part in this study,
you may find that you have less desire to smoke, and you may cut back on your own. The
reason we ask about your smoking and test your carbon monoxide is that we would like to
check on any changes in your smoking, both for your safety and to study the effects of
sarcosine.
THE BRAIN SCANNING PROCEDURES AT MCLEAN HOSPITAL (Initial Visit and Week 6)
On the Initial Visit and at the week 6 visit, we will ask you to complete a brain scanning
session at McLean Hospital.
The following screening procedures will take place every time you go to at McLean Hospital:
1. Urine sample to be tested for the presence of illegal drugs
2. Exhaled breath to test for recent alcohol use
3. Magnetic resonance brain scan
We will ask you to begin fasting overnight starting at 9 pm the evening before each brain
scan. Please do not eat or drink any products or beverages that contain caffeine. Please
do not smoke tobacco cigarettes on the study day.
The brain scans are magnetic resonance imaging and magnetic resonance spectroscopy scans.
Magnetic resonance imaging (MRI) uses a strong magnet and radiofrequency waves to produce
images of the brain. Magnetic resonance spectroscopy (MRS) is a similar tool that measures
chemicals within the brain. These MRI and MRS scans will be done at the McLean Hospital
Brain Imaging Center. You will have the scans in two different scanners. Only one scanner
will be used at the Screening Visit.
After the Screening Visit, there will be two scanning sessions, at the Initial Visit and at
week 6. Each scanning session will take about 1 hour. Each session includes several short
scans, and the longest scan will take about 20 minutes. You will be given short breaks
between each scan. |
| Criteria: |
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INCLUSION CRITERIA:
1. Women and men aged 18-65 with DSM-IV diagnosis of schizophrenia or schizoaffective
disorder by diagnostic interview and chart review.
2. Clinically stable on a stable dose of antipsychotic medication for at least one
month, no current active suicidal ideation.
3. Competent to provide informed consent.
4. Women of childbearing age must have a negative pregnancy test at screening and agree
to use an approved form of contraception throughout the study.
5. Current smokers of at least 10 cigarettes per day.
6. Screening labs within normal limits for age and gender except for liver function
tests as specified below.
EXCLUSION CRITERIA:
1. Diagnosis of bipolar disorder, dementia, neurodegenerative disease, or other organic
mental disorder.
2. History of seizure disorder or CNS tumor.
3. Liver function tests elevated over twice normal.
4. Bulimia, or major depressive disorder within the last 6 months.
5. 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.
6. Use of investigational medication within 30 days of enrollment.
7. Use of clozapine.
8. Substance use disorder other than nicotine or caffeine in the last 6 months (by self
report and salivary drug and alcohol screen).
9. Patients who, in the investigator's opinion, pose a current severe homicide or
suicide risk.
10. People with implanted metal devices that would make participation in MRI/MRS
procedures unsafe.
11. Claustrophobia
12. Weight >275 lbs.
13. Past use of dietary glycine or sarcosine supplement
14. History of brain or heart surgery or stroke
15. Myocardial Infarction in the past 6 months |
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| Study is available at: |
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Freedom Trail Clinic, Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Alice Coakley, B.A.
Email: acoakley1@partners.org
Phone: 617-912-7863
Secondary Contact:
Alice Coakley, B.A.
Email: acoakley1@partners.org
Phone: 617-912-7863 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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