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Contact Information:

Prof John Geddes


Study Location:

University of Oxford
Oxford
OX3 7JX


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OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Schizophrenia


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Not provided at time of registration

Primary hypothesis: Mirtazapine add-on therapy is superior to placebo in the treatment of symptoms in people with schizophrenia, measured by the Positive and Negative Syndrome Scale (PANSS). Secondary hypotheses: Folic acid is superior to placebo as add-on therapy in the treatment of symptoms in patients with schizophrenia, measured by the PANSS.

Please note that as of 22/09/10 this record has been updated. Updates can be found in the relevant field with the above update date. Please also note that the trial will no longer be taking place in centres in China, as was intended at the time of registration.


Multicentre randomised double-blind placebo-controlled 2x2 factorial trial

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2010

31 Dec 2012

Interventional

Intervention Type : Drug
Intervention Description : Participants are randomly allocated to mirtazapine or placebo and separately to folic acid or placebo 1. Mirtazapine or placebo 2. Folic acid or placebo Both as add-on therapies to ongoing antipsychotic treatment

Both allocated medicines are taken orally for 12 weeks with a 2-week tapering period for mirtazapine on completion of the trial. The dose of mirtazapine is 30mg and of folic acid 400 - 500microg. (Participants for whom random allocation of folic acid/placebo is not appropriate can take part in the trial and be randomly allocated to lamotrigine or placebo only.)


You can take part if:


1. Diagnosis of DSM-IV schizophrenia 2. Active psychotic symptoms - i.e. hallucinations, delusions, thought disorder3. Inpatient or outpatient4. Aged 18 to 70 years. 5. Able and willing to consent to participate 6. Minimum score on PANSS 607. Drug treatment stable8. Currently taking effective dose of antipsychotic 9. Adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain whether it will offer any benefit 10. Clinically appropriate to change or augment treatment. Participants for whom random allocation of folic acid or placebo is not appropriate will be allocated mirtazapine or placebo only.

Ammended 22/09/10:4. 16-70 years




You may not be able to take part if:

1. Not meeting criteria for current manic episode including schizoaffective disorder2. No antidepressant treatment within last two weeks and not considering treatment for depression 3. Not taking clozapine4. No contraindication to investigational medicinal products5. Not pregnant, breast-feeding or planning a pregnancy


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Oxford
    Oxford
    OX3 7JX

Prof John Geddes



The study is sponsored by University of Oxford (UK) and funded by Stanley Medical Research Institute (USA).



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for Trial ID: ISRCTN32434568

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