OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A randomised, double-blind, 2x2 factorial trial - OCTUMI-4

niversity of Oxford0 个研究点目标入组 53 人开始时间: 2010年7月19日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1. Able and willing to consent to participate.
•2. Diagnosis of DSM-IV schizophrenia.
•3. Active psychotic symptoms – i.e. hallucinations, delusions, thought disorder.
•4. Clinically appropriate to change or augment treatment.
•5. Adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain if it will offer any benefit.
•6. Currently taking effective dose of antipsychotic (according to dose range given in the British National Formulary).
•7. Aged 18 to 75 years.
•8. Adhering to antipsycotic treatment.
•9. Minimum score on PANSS 60.
•10. Drug treatment stable.
•11. Inpatient or outpatient
•12. Not pregnant, breast-feeding or planning a pregnancy
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Meeting criteria for current hypomanic or manic episode
•2. Meeting criteria for current depressive episode
•2. Current (i.e. within last two weeks) antidepressant treatment or considering treatment for depression.
•3. Contraindications to investigational medicinal products*.
•4. Currently taking clozapine.
•* If contraindication is to folic acid, the patient can be randomised to the mirtazapine / placebo comparison only.

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