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

IVERSITY OF OXFORD0 个研究点目标入组 334 人开始时间: 2012年8月2日最近更新: 2013年12月23日

适应症

试验速览

暂无简介。

•1. diagnosis of DSM-IV schizophrenia; 2. active psychotic symptoms (i.e. hallucinations, delusions, thought disorder); 3. minimum PANSS score 60; 4. inpatient or outpatient; 5. aged 16 to 70 years; 6. able and willing to consent to participate; 7. currently taking effective dose of antipsychotic; 8. clinically appropriate to change or augment treatment; 9. adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain whether it will offer any benefit; 10. not pregnant, breast-feeding or planning a pregnancy; 11. adhering to antipsychotic treatment; 12. drug treatment stable.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

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

发起方

IVERSITY OF OXFORD