ISRCTN77257074终止3 期
AnTiconvuLsant AugmeNtation Trial In Schizophrenia: a randomised, pragmatic double-blind, placebo-controlled trial to assess the effectiveness of valproate augmentation of antipsychotic treatment in patients with residual psychotic symptoms
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 371
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 04/05/2021:
- •1. Aged 18 and above at the time of consent
- •2. Adequate command of English to understand the information leaflet
- •3. Capacity to consent to participation in the study
- •4. Confirmation of DSM-5 diagnosis of schizophrenia or schizoaffective disorder using SCID-5
- •5. PANSS total symptom severity score > 70
- •6. At least one PANSS psychotic item rating of at least moderate severity (> 3 on one or more psychotic item rating in PANSS)
- •7. Received treatment with at least one non-clozapine antipsychotic drug at adequate dose (as defined by Maudsley guidelines)for a duration of at least 6 weeks and in case of a depot be stable for at least 2 treatment cycles or at least 30 days
- •8. On a stable dose of antipsychotic treatment for at least 2 weeks in case of oral dosage forms
- •9. Good adherence to antipsychotic treatments as determined by a score > 4 on the Medication Adherence rating scale
- •10. Female subject of child bearing potential must agree to the MHRA pregnancy prevention programme which includes a negative serum pregnancy test, use of a highly effective form of birth control and signing an annual risk acknowledgement form
- •Previous inclusion criteria:
- •1. Aged 18 and above at the time of consent
- •2. Adequate command of English to understand the information leaflet
- •3. Capacity to consent to participation in the study
- •4. Confirmation of DSM-5 diagnosis of schizophrenia or schizoaffective disorder using SCID-5
- •5. PANSS total symptom severity score > 70
- •6. At least one PANSS psychotic item rating of at least moderate severity (> 3 on one or more psychotic item rating in PANSS)
- •7. Received treatment with at least one non-clozapine antipsychotic drug at adequate dose (as defined by Maudsley guidelines)for a duration of at least 6 weeks and in case of a depot be stable for at least 2 treatment cycles or at least 30 days
- •8. On a stable dose of antipsychotic treatment for at least 2 weeks in case of oral dosage forms
- •9. Good adherence to antipsychotic treatments as determined by a score > 4 (ideally > 6) on the Medication Adherence rating scale
- •10. Female subject of child bearing potential must agree to the MHRA pregnancy prevention programme which includes a negative serum pregnancy test, use of a highly effective form of birth control and signing an annual risk acknowledgement form
排除标准
- •1. Subject having a rating of 4 or above on the clinical frailty scale
- •2. Female subject who is pregnant or breast-feeding
- •3. Subject with a known history of urea cyclic disorder
- •4. Subject with a known history of porphyria
- •5. Subject with a known history of severe renal insufficiency
- •6. Subject with a known history of a mitochondrial disorder and in the opinion of the recruiting researcher will impair the safety of the subject and/or the scientific integrity of the study
- •7. Subject with carnitine palmitoyltransferase (CPT) type II deficiency
- •8. Subject currently taking clozapine
- •9. Subject currently taking valproate
- •10. Subject who had stopped taking valproate in the past six weeks prior to screening due to adverse effects
- •11. Any recent change (<2 weeks) change in antipsychotic regimen
- •12. Subject answers yes” to Suicide Ideation” Items 4 (active suicide ideation) with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSR during the screening visit
- •13. Subject has attempted suicide within 3 months prior to screening
- •14. Subject having known hypersensitivity to valproate or other ingredients in the tablet or placebo
- •15. Significant sustained abnormality when vital signs are measured at screening
- •16. Patients with a personal or family history of significant liver disease (e.g. severe hepatic dysfunction, cirrhosis)
- •17. Any other medical condition in the opinion of the recruiting researcher that will impair the safety of the subject and/or the scientific integrity of the study
- •18. Participation in a clinical trial within 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- •19. Participation in a research study that in the opinion of the investigator will affect the safety of the volunteer or scientific integrity of either study
- •20. Taking a drug that may have a clinically significant effect on the metabolism of valproate or where valproate may have a clinically significant effect on its metabolism including oxcarbazepine, lamotrigine, phenobarbital, primidone, phenytoin, ethosuximide, rufinamide, phenytoin, carbapenem antibiotics, topiramate, acetazolamide, warfarin and other coumarin anticoagulants and in the opinion of the recruiting researcher will impair the safety of the subject and/or the scientific integrity of the study
- •(added 04/05/2021)
- •21. Women of childbearing potential unwilling to follow the study contraception requirements
- •22. Subject with a known history of active liver disease
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