NL-OMON43400已完成3 期
A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients with Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation. - REMISSIO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia
- •* Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
- •* Willing and able to fill out self-administered questionnaires
- •* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- •* A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline
- •* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
排除标准
- •* His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder)
- •*has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM-5 definition of moderate to severe substance use disorder (except for nicotine or caffeine) within 6 months prior to screening. However, subjects with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment.
- •* Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M)
- •* Has a known hypersensitivity to paliperidone or risperidone
- •* Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M)
- •* Has received clozapine during the last 3 months before the Screening visit.
- •* Is considered to be at imminent risk of suicide, even after clinical intervention
- •* Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
- •* Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- •* Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M
- •* has participated in an investigational drug trial in the 30 days prior to the screening visit or is currently enrolled in an investigational study*Dementia related psychosis* and *Inherited or acquired long QT interval syndrome* are implicitly included within exclusion criterion 1.
研究者
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