Schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
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 antipsy
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland, Italy, United Kingdom
Outcome results
None listed