Schizophrenia
CURRENT PROJECTS - SCHIZOPHRENIA
Investigating the effects of adjunct glycine therapy on cognitive function in schizophrenia
Background
Glycine is an amino acid that is found in the body and the levels of this amino acid are often low in patients with schizophrenia. Some studies have found that glycine may improve schizophrenia symptoms when administered in conjunction with mainstream medications. However, glycine treatment has been found to be effective only in some patients. The efficacy of this treatment may be related to the levels of glycine in the body before treatment.
This study is a 6 week randomised controlled trial (RCT) investigating the use of glycine in schizophrenia and its effects on mismatched negativity (EEG) and cognition.
Aim
The aim of the study is to clarify the relationship between baseline glycine levels and the effect of adjunct glycine therapy (glycine + antipsychotic medication) on cognitive function in schizophrenia.
Participants
Twenty-five men and twenty-five women with schizophrenia, aged 18-45 years, who are currently on stable atypical antipsychotics other than clozapine, will be recruited for this study.
Methods
Half of the participants will receive adjunct glycine therapy for 6 weeks, and the other half placebo (glucose) for 6 weeks. Testing will include blood sampling, cognitive testing, symptom assessment and brain activity recording before and after acute, and after chronic (6 weeks) glycine treatment.
Primary Researcher
Ms. Amity Green
Searchlyte
Schizophrenia affects one person in every 100. Medications called antipsychotics are often used to treat the symptoms of schizophrenia, but some people continue to have symptoms despite antipsychotic treatment. Your doctor might call these sub-optimally controlled symptoms, and they can include feeling that others are talking about you, hearing noises or voices that others don’t hear, seeing things others may not experience and having difficulty organising your thoughts or making people understand you. New clinical studies are needed to find out whether investigational treatments can help these symptoms.
SearchLyte is a program of studies evaluating an investigational treatment for schizophrenia. The studies in this part of the program are trying to find out if the investigational medication improves the sub-optimally controlled symptoms of schizophrenia when given with a patient’s usual antipsychotic medication. About 600 patients worldwide will take part in each study. The studies are very similar. Your doctor will tell you which study you will be joining.
What will the SearchLyte Program involve?
If you join the study, you will need to visit the clinic approximately 20 times over about 60 weeks. This ill include one visit for the study doctor to check if the study is suitable for you. Each visit could last –8 hours. If possible, you should come to the visits with your caregiver (someone who sees and helps you regularly, such as a family member, nurse or social worker). If your caregiver cannot come with you they must agree to be contacted by phone during the study.
What medication will I be given?
You will be given the investigational medication or placebo (a sugar pill) to add to your usual antipsychotic medication. The treatment you get will be decided by chance (like flipping a coin) and neither you nor the study team will know which you are receiving.
What will happen at the clinic visits?
The clinic visits will include a number of checks including questions about your health and use of medications, a physical check-up, blood and urine samples, an electrocardiogram (a simple test to ssess the electrical activity of your heart), eyesight checks, and some checks on attention, memory and concentration.
At the end of the study you will have the option to continue to take the investigational medication (or switch to the investigational medication if you have been taking placebo) for another 3 years.
Can I take part in the SearchLyte Program?
You may be able to take part in the SearchLyte Program if you:
- are at least 18 years of age
- have been diagnosed with schizophrenia
- are taking one or two antipsychotic medications but still have symptoms of schizophrenia
- have not had significant changes in your symptoms or been hospitalised during the past 3 months
- have a caregiver who sees you for more than 4 hours every week and is willing to take part in the study with you.
It is up to you and your caregiver to decide whether you wish to take part, and you can choose to leave the study at any time.
Why should I take part in the SearchLyte Program?
You may or may not benefit by joining the SearchLyte Program. However, by taking part you could:
- contribute to research that may help others with schizophrenia in the future
- receive study-related monitoring from a team of experienced doctors and nurses.
It is important to understand some of the potential risks of participating:
- There is a one-in-three chance that you will receive placebo instead of the investigational medication, although you will continue to take your usual antipsychotic medication.
- As with all medications, side effects can occur. The study doctor will discuss these with you.
What do I do now?
If you are interested in learning more about the SearchLyte Program, please discuss it with your caregiver first because he/she will play an important part in the study.
You may also find it helpful to speak with your regular doctor before agreeing to participate. The study centre staff will be pleased to give you more information about the study and answer any of your questions. Please contact us on 9076 6589 for more information.
Primary Researcher
Ms. Erica Hannagan
Ondansetron study: Double-Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Chronic Residual Schizophrenia
Schizophrenia is associated with positive symptoms such as hallucinations or delusions; negative symptoms which might include lack of emotion or motivation; and cognitive symptoms such as difficulty with memory. Schizophrenia is typically treated with antipsychotic medications, and while this medication often helps alleviate positive symptoms, the negative and cognitive symptoms frequently persist.
What is the study investigating?
The purpose of this study is to investigate the use of the medication Ondansetron as an adjunctive or add-on therapy to existing anti-psychotic medication in the treatment of schizophrenia symptoms. Ondansetron is a well established medication which is approved in Australia for the treatment of drug-induced nausea and vomiting. However, various case studies and clinical studies have shown Ondansetron to also be effective in the treatment of symptoms associated with persistent schizophrenia. This study will examine whether Ondansetron in combination with standard antipsychotic medication is more effective in improving the symptoms of schizophrenia than antipsychotic medication alone.
What will I need to do?
If you decide to participate and the study doctor determines that you qualify for inclusion, your total period of participation will last approximately 12-13 weeks, which will include five visits. During this time you must be willing to attend the scheduled visits; complete a number of questionnaires and cognitive tests and be interviewed about your symptoms of schizophrenia. You will also be required to undergo health checks and give a blood and urine sample at visit 1 & 5. It is also important that you take the study medication each day as directed.
What medication will I be given?
You will be randomly allocated (a method involving chance) to either the Ondansetron medication or a placebo (a non-active medication). This study is double-blind, meaning that neither you nor the researcher will know whether you are on the active medication or a placebo. You will be informed at the end of your last session whether you were taking the Ondansetron or placebo.
Can I take part in the Ondansetron study?
You may be able to take part in the Ondansetron study if you:
- Aged between 18-65 years
- Current diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
- Current treatment with a stable and standard dose of an antipsychotic medication
- Ability to provide informed consent
What do I do now?
If you are interested in learning more about the Ondansetron study, please feel free to contact Penny Weeks at the Monash Alfred Psychiatry Research Centre on 9076 6590. You may also find it helpful to speak with your regular doctor or psychiatrist before agreeing to participate.
Primary Researcher
Ms. Penny Weeks
