A Study of the Effects of Sarcosine on Symptoms and Brain Glycine Levels in People With Schizophrenia (Sarc)
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Sarcosine, Glycine, Magnetic Resonance Spectroscopy, Schizophrenia
Eligibility 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.
- 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).
- Posing a current risk of homicide or suicide.
Sites / Locations
- McLean Hospital, Brain Imaging Center
- MGH Center for Addiction Medicine
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Sarcosine
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.
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.