EUCTR2011-001351-37-SK进行中（未招募）1 期
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults with Major Depressive Disorder, the Orion Trial. - Orion
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects are required to meet the following inclusion criteria:
- •1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
- •2. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and understand the written word in order to complete subject-reported outcomes measures; and to be reliably rated on assessment scales.
- •3. Subjects who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 as adjunctive therapy to their antidepressant therapy and who meet one of the following criteria:
- •a) Subjects who completed participation in the Double-blind Randomization Phase (ie, Week 14 visit of Phase B) in Trial 331-10-227 or Trial 331-10-228 or
- •b) Subjects who met criteria for a response at the end of prospective treatment (ie, Week 8 visit of Phase A) in Trial 331-10-227 or Trial 331-10-228, BUT DID NOT meet criteria for remission (defined as a MADRS Total Score of = 10) at the Week 14 visit of Phase A+ in Trial 331-10- 227 or Trial 331-10-228.
- •4. Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent for Trial 331-10-238.
- •5. Subjects willing to discontinue all prohibited psychotropic medications starting from the time of signing the ICF and during the trial period.
- •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 1230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •For full details on exclusion criteria please refer to Section 3.4.3 of the trial protocol.
- •Subjects will be excluded if they meet any of the following selected exclusion criteria:
- •1. Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who will not remain abstinent during the trial and for 30 days after the last dose.
- •2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712 in Trial 331-10-238.
- •3. Subjects with a major protocol violation during the course of their participation in the double-blind phase 3 trial (ie, Trial 331-10-227 or Trial 331-10-228).
- •4. Subjects who have received ECT for the current depressive episode.
- •5. Subjects who have had an inadequate response to ECT at any time in the past or who have had a vagus nerve stimulation or deep brain stimulation device implanted for management of treatment resistant depression.
- •6. Subjects with a current need for involuntary commitment or who have been hospitalized during Trial 331-10-227 or Trial 331-10-228 for the current major depressive episode.
- •7. Subjects with a current Axis I (DSM-IV-TR) diagnosis of:
- •Delirium, dementia, amnestic or other cognitive disorder
- •Schizophrenia, schizoaffective disorder, or other psychotic disorder
- •Bipolar I or II disorder
- •Eating disorder (including anorexia nervosa or bulimia)
- •Obsessive compulsive disorder
- •Panic disorder
- •Post-traumatic stress disorder
- •8. Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
- •9. Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode.
- •10. Subjects receiving new onset psychotherapy (individual, group, marriage, or family therapy) during Trial 331-10-227 or Trial 331-10-228.
- •11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this trial.
- •12. Any subject who, in the opinion of the investigator, should not participate in the trial.
研究者
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