A Trial of the Effects of Glycine Loading on Clinical Symptoms and Logical Memory in Patients With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Scale for the Assessment of Negative Symptoms (SANS) total score
研究概览
简要总结
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.
详细描述
If you agree to participate in this study, you will be taking glycine or a placebo for 12 weeks - in two 6-week periods. These two 6-week periods are separated by a 2-week "wash-out" period where you take no study medication. During one of the 6-week periods, you will be taking glycine. During the other 6-week period, you will be taking placebo. Neither you nor the study staff will know in which order you receive the glycine or placebo. In case of an emergency, we can quickly find out which medication you have been taking.
If you agree to participate in this study, we will then meet for a "screening visit" to see if you are eligible for participation in the study. You will have an interview where you will be asked about your history of psychiatric illness. We will also ask about your previous history with smoking and use of other drugs and about your current medications. We will ask you to sign an authorization form so that we can look at your medical record. We will review your medical record for medical and psychiatric diagnoses and treatment. We will check your heart rate and blood pressure. We will take a saliva (spit) sample to check for use of street drugs such as alcohol, cocaine, amphetamines, opiates, and marijuana. If you test positive for the presence of any of these substances, you will not be allowed to participate in the study. Information about drug use will not become a part of your medical record, but this information will become a part of your research record.
After you have completed this screening interview, we will arrange a date and time for you to come back for an initial assessment before the start the study. The initial assessment takes about an hour and a half. During this assessment we will ask you questions about different psychiatric symptoms that you may be having. You will be asked about your thinking, mood, unusual experiences such as hearing voices, side effects from antipsychotic medications, and smoking behavior.
You will have the carbon monoxide in your breath measured. Carbon monoxide is a gas contained in cigarette smoke, and measuring the level of carbon monoxide in your breath helps us to tell whether or not you smoke cigarettes. To measure your carbon monoxide, we will have you breathe into a small hand-held machine.
We will also ask you about your regular activities during the day and what kind of hobbies/interests you have. Then you will do a memory test where the interviewer will tell you a story and ask you to repeat it back to him.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
Scale for the Assessment of Negative Symptoms (SANS) total score
时间窗: 14 weeks
次要结局
- Brief Psychiatric Rating Scale (BPRS) positive symptom subscale(14 weeks)
- Performance on the Logical Memory subtest of the Wechsler Memory Scale(14 weeks)
- Correlations between changes in clinical symptoms and changes in brain glycine levels as measured by MRS at McLean Hospital(14 weeks)