OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia
| ISRCTN | ISRCTN32434568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32434568 |
| Secondary identifying numbers | RECOVERY [OCTUMI-4] |
- Submission date
- 26/11/2009
- Registration date
- 18/01/2010
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof John Geddes
Scientific
Scientific
University of Oxford
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
Study information
| Study design | Multicentre randomised double-blind placebo-controlled 2x2 factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A Large Simple 2x2 Factorial Trial |
| Study acronym | 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. |
| Ethics approval(s) | The Oxford Research Ethics Committee C, 26/07/2010, ref: 10/HO606/24 |
| Condition | Schizophrenia |
| Intervention | 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.) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mirtazapine, folic acid |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/04/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 334 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2010 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- England
- Finland
- Italy
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.ox.ac.uk |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
Stanley Medical Research Institute (USA)
Private sector organisation / Research institutes and centers
Private sector organisation / Research institutes and centers
- Alternative name(s)
- The Stanley Medical Research Institute, SMRI
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
