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11 February 2012
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| [ Print-friendly version ] |
| OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia |
| ISRCTN | ISRCTN32434568 |
| ClinicalTrials.gov identifier | |
| Public title | OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia |
| Scientific title | OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A Large Simple 2x2 Factorial Trial |
| Acronym | OCTUMI-4 |
| Serial number at source | RECOVERY [OCTUMI-4] |
| Study hypothesis |
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. |
| Lay summary | |
| Ethics approval |
Added 22/09/10:
The Oxford Research Ethics Committee C approved on the 26th of July 2010 (ref: 10/HO606/24) |
| Study design | Multicentre randomised double blind placebo controlled 2x2 factorial trial |
| Countries of recruitment | Finland, Italy, United Kingdom |
| Disease/condition/study domain | Schizophrenia |
| Participants - inclusion criteria |
1. Diagnosis of DSM-IV schizophrenia
2. Active psychotic symptoms - i.e. hallucinations, delusions, thought disorder 3. Inpatient or outpatient 4. Aged 18 to 70 years. 5. Able and willing to consent to participate 6. Minimum score on PANSS 60 7. Drug treatment stable 8. 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 |
| Participants - exclusion criteria |
1. Not meeting criteria for current manic episode including schizoaffective disorder
2. No antidepressant treatment within last two weeks and not considering treatment for depression 3. Not taking clozapine 4. No contraindication to investigational medicinal products 5. Not pregnant, breast-feeding or planning a pregnancy |
| Anticipated start date | 01/04/2010 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 334 |
| Interventions |
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.) |
| Primary outcome measure(s) |
Reduction of symptoms of schizophrenia assessed using the PANSS
Both primary and secondary outcomes will be measured at baseline and then at 4, 8 and 12 weeks |
| Secondary outcome measure(s) |
1. Reduction of negative symptoms of schizophrenia assessed using the PANSS
2. Change in depressive symptoms 3. Tolerability of trial treatment 4. Adverse effects including akathisia and extra pyramidal symptoms |
| Sources of funding | Stanley Medical Research Institute (USA) |
| Trial website | |
| Publications | |
| Contact name | Prof John Geddes |
| Address |
University of Oxford
Department of Psychiatry Warneford Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 7JX |
| Country | United Kingdom |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 26/11/2009 |
| Last edited | 09/05/2011 |
| Date ISRCTN assigned | 18/01/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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