University of Oxford
If you are interested in taking part in the study or want to find out more please write, email or The trial is open to people with schizophrenia who are aged 18—75 and who have moderate / People who are being treated with clozapine.
Evaluation of Mirtazapine
and Folic Acid
You can withdraw from the study at any time.
for Schizophrenia
OCTUMI-4 is being conducted by OCTUMI,
The Oxford Clinical Trials Unit
for Mental Illness
Chief Investigator—Professor John Geddes
You will be seen by a member of the trial team every 4 weeks whilst you are in the study.
Yes, as a thank you for the time and effort you The University of Oxford is
give to the trial we will offer you £10 cash at each sponsoring the trial
Funding is being provided by the
The Stanley Medical Research Institute, a charita- Stanley Medical Research Institute
ble organisation which supports research into the causes and treatments of schizophrenia The OCTUMI-4 Trial - what is it all about?
Study flow chart What does the trial involve? The trial involves being asked some ques- Screening visit
Consent to participate
your medications. We can visit you at home Eligibility check /Symptom
Antipsychotic medications are widely used in or in the hospital, whichever you prefer. ratings / Blood sample
You would be seen on five occasions dur-ing the study when you will be asked about the treatment of psychiatric illness and though 7-14 days Run-in phase
Just taking your regular antipsychotic medications
these medications are very useful sometimes At the beginning and end of the study we Randomisation visit
Baseline data/Symptom ratings / Blood sample
Allocated to one of four treatment groups
also like to use the sample for genetic re- We have been studying the use of an antidepres- search but if you do not want us to do this, Mirtazapine +
Mirtazapine +
Folic Acid
Folic Acid Placebo
sant called mirtazapine and recent trials have You will carry on with your regular medica- tion and be given two extra tablets. One indicated that adding this medication to antipsy- Antipsychotic
will be mirtazapine or what is called a pla-cebo or dummy tablet. The other will be chotics can help improve the symptoms of Mirtazapine Placebo +
Mirtazapine Placebo
folic acid or placebo. You will not know Folic Acid
schizophrenia. We have also been studying a Folic Acid Placebo
domised controlled trial which is the best vitamin called folic acid which seems to be Antipsychotic
way to see if the medications are effective. Antipsychotic
You are free to leave the study at any time and do not have to give a reason to do so.
lower in people with mental health problems Week 4 follow-up visit
What are the benefits of taking part? and has been associated with low mood.
If the mirtazapine and folic acid are effec-tive and you are allocated to one of both Week 8 follow-up visit
then your health might benefit. If you are To find out if this medication and vitamin can Week 12 follow-up visit
help people feel better when added to antipsy- Repeat blood sample
readily available to you while you are in the study if you have any problems or need any help or advice. We hope that this addi- chotic medication we need to do what is called a 2 week tapering phase
tional support will be helpful to you.
We will reimburse you for your travel or Phone call to see how you are
any other reasonable expenses involved in taking part in the study.

Source: http://www.oxfordmhf.org.uk/researchad/OCTUMI4_Schizophrenia_trial_patientinfo.pdf


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