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

ISRCTN	ISRCTN32434568
DOI	https://doi.org/10.1186/ISRCTN32434568
Protocol serial number	RECOVERY [OCTUMI-4]
Sponsor	University of Oxford (UK)
Funder	Stanley Medical Research Institute (USA)

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 of protocol

Not provided at time of registration

Contact information

Prof John Geddes
Scientific

University of Oxford
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled 2x2 factorial trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mirtazapine, folic acid
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
Key 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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	334
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

United Kingdom
England
Finland
Italy

Study participating centre

University of Oxford

Oxford
OX3 7JX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.