Condition category
Mental and Behavioural Disorders
Date applied
26/11/2009
Date assigned
18/01/2010
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Geddes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RECOVERY [OCTUMI-4]

Study information

Scientific title

OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A Large Simple 2x2 Factorial Trial

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

The Oxford Research Ethics Committee C, 26/07/2010, ref: 10/HO606/24

Study design

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Mirtazapine, folic acid

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

334

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

Finland, Italy, United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Research organisation

Funder name

Stanley Medical Research Institute (USA)

Alternative name(s)

SMRI

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes