OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia
- Conditions
- SchizophreniaMental and Behavioural Disorders
- Registration Number
- ISRCTN32434568
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 334
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of symptoms of schizophrenia assessed using the PANSS<br>Both primary and secondary outcomes will be measured at baseline and then at 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method 1. Reduction of negative symptoms of schizophrenia assessed using the PANSS<br>2. Change in depressive symptoms<br>3. Tolerability of trial treatment<br>4. Adverse effects including akathisia and extra pyramidal symptoms