EUCTR2011-001350-28-SK进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder, the Pyxis Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
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. Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- •4. Subjects with both a diagnosis of MDD, and in a current Major Depressive Episode, as defined by DSM-IV-TR criteria and confirmed by both the MINI and an adequate clinical psychiatric evaluation. The current Major Depressive Episode must be >= 8 weeks in duration. In addition, subjects must have reported a history for the current Major Depressive Episode of an inadequate response to at least one and no more than three adequate antidepressant treatments. An inadequate response is defined as < 50% reduction in depressive symptom severity, as assessed by the ATRQ. Adequate treatment is defined as an antidepressant treatment for at least 6 weeks in duration at a minimum dose (or higher) as specified in the ATRQ. If the subject showed >= 50% improvement on any antidepressant treatment in the current episode, then the subject must have had an inadequate response to a subsequent adequate antidepressant treatment (as defined above by the ATRQ) of another antidepressant drug prior to entry into the trial. For the most recent antidepressant treatment, the subject must not report >= 50% improvement (as defined above by the ATRQ).
- •5. Subjects with a HAM-D17 Total Score >= 18 at the Screening and Baseline visits.
- •6. Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.
- •Inclusion Criteria Required for Entry into Phase B (Double-blind Randomization Phase):
- •7. HAM-D17 Total Score >= 14 at the Week 8 visit
- •8. HAM-D17 Total Score at the Week 8 visit that is less than a 50% reduction from baseline value
- •9. CGI-I score >= 3 at the Week 8 visit
- •10. As evaluated by the investigator, the subject is suitable for randomization based on all available clinical, efficacy, and safety data collected during Phase A in addition to HAM-D17 and CGI-I scores.
- •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 680
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •For full details on exclusion criteria please refer to Section 3.4.3 of the trial protocol.
- •Details of the exclusion criteria around the target population are included below.
- •Subjects will be excluded if they meet any of the following exclusion criteria:
- •Subjects who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three monotherapy antidepressant treatments during the current Major Depressive Episode at a therapeutic dose and for an adequate duration (minimum duration of six weeks), including any antidepressant that the subject may be taking at screening if it meets the criteria for adequate treatment.
- •Subjects who report treatment with adjunctive antipsychotic medication with an antidepressant for a minimum of three weeks during the current Major Depressive Episode
- •Subjects who have received ECT for the current Major Depressive Episode.
- •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
- •Subjects with a current need for involuntary commitment or who have been hospitalized within four weeks of screening for the current Major Depressive Episode.
- •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
- •Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
- •Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current Major Depressive Episode.
- •Subjects who answer Yes” on the C-SSRS either Suicidal Ideation Item 4 or C-SSRS Suicidal Ideation Item 5 whose most recent episode meeting criteria was within the past 6 months or Subjects who answer Yes” on any of the 5 C-SSRS Suicidal Behavior Items and whose most recent episode meeting criteria for any of the occurred within the last 2 years
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
研究者
相似试验
进行中（未招募）
1 期
A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic ArthritisActive Psoriatic ArthritisMedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859EUCTR2016-001163-37-PLJanssen-Cilag International N.V.360
撤回
3 期
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)chronic immune thrombocytopeniaITP1003553410003816NL-OMON37816Eisai2
进行中（未招募）
1 期
A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic ArthritisActive Psoriatic ArthritisMedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859EUCTR2016-001163-37-ESJanssen-Cilag International N.V.360
进行中（未招募）
3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of SR-0379 in Participants with Skin Ulcerskin ulcerJPRN-jRCT2031210266Ichioka Shigeru120
进行中（未招募）
1 期
A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaChronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)MedDRA version: 14.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-000830-12-BEEisai Limited84