EUCTR2011-002514-37-PL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 Maintenance Treatment in Adults with Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •1. Subjects who are able to provide written informed consent (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 ingestion, and discontinuation of
- •prohibited concomitant medication, and to be reliably rated on
- •assessment scales.
- •3. Subjects with a current diagnosis of schizophrenia, as defined by
- •DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and
- •Psychotic Disorders Studies, and a history of the illness for at least three
- •years prior to screening
- •4. Subjects who are currently being treated with oral antipsychotics
- •other than clozapine and who, in the opinion of the investigator, require
- •chronic treatment with antipsychotic medication and could potentially
- •benefit from monotherapy treatment with oral brexpiprazole for
- •schizophrenia.
- •5. Subjects who have been stable on antipsychotic medication or an
- •antipsychotic regimen for at least one 3-month period in the last year
- •prior to screening
- •6. Male and female subjects 18 to 65 years of age
- •7. Subjects willing to discontinue all prohibited psychotropic medications
- •to meet protocol-required washouts prior to and during the trial period.
- •Inclusion Criteria for Rollover Subjects from Trial 331-10-232
- •8. Subjects who, in the opinion of the investigator, could potentially
- •benefit from administration of oral brexpiprazole for the treatment of
- •schizophrenia and who meet one of the following criteria:
- •- Completed the Double-blind Maintenance Phase (i.e., Week 52 visit) of
- •Trial 331-10-232
- •- Met criteria for exacerbation of psychotic symptoms/impending
- •relapse during the Double-blind Maintenance Phase (Phase C) of Trial
- •331-10-232 and were withdrawn from the trial
- •- Was participating in Phase A, B, or C of Trial 331-10-232 at the time of
- •early trial termination due to a positive result from a planned interim
- •- Was participating in Phase A, B or C of Trial 331-10-232 when the trial
- •reached its conclusion
- •Inclusion Criteria Assessed Prior to Entry into Phase A
- •8. Adequate washout of prohibited concomitant medications, including 3
- •days prior to entry into Phase A for mood stabilizers and antidepressants
- •9. Subject is receiving antipsychotic(s) other than clozapine. These
- •subjects must be cross-titrated to brexpiprazole monotherapy over 4
- •weeks using an initial dose of 1 mg to achieve a recommended target
- •starting dose in Phase B of 2 mg/day
- •Inclusion Criteria Assessed Prior to Entry into Phase B
- •10. Adequate washout of prohibited concomitant medications, including
- •14 days prior to entry into Phase B for mood stabilizers and
- •antidepressants
- •11. Subject is ready to receive oral brexpiprazole as monotherapy for
- •treatment of schizophrenia.
- •12. Outpatient status. Subjects hospitalized at the investigator's
- 另有 8 项未显示
排除标准
- •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 brexpiprazole
- •3. Subjects with a major protocol violation during the course of their
- •participation in the double-blind phase 3 trial (ie, Trial 331-10-230, Trial
- •331-10-231, or Trial 331-10-232).
- •4. Subjects with schizophrenia who are considered resistant/refractory
- •to antipsychotic treatment by history or who have a history of failure to
- •respond to clozapine or response to clozapine treatment only.
- •5. Subjects with a current DSM-IV-TR Axis I diagnosis other than
- •schizophrenia including, but not limited to schizoaffective disorder, MDD,
- •bipolar disorder, post-traumatic stress disorder, anxiety
- •disorders, delirium, dementia, amnestic or other cognitive disorders.
- •Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid,
- •or antisocial personality disorder or mental
- •retardation.
- •6. Subjects experiencing acute depressive symptoms within the past 30
- •days, according to the investigator's opinion, that require treatment with
- •an antidepressant.
- •7. Subjects with a significant risk of violent behavior
- •8. Subjects with clinically significant tardive dyskinesia, as determined
- •by a score of = 3 on Item 8 of the AIMS at entry
- •9. Subjects with a score of 5 (severe akathisia) on the BARS global
- •clinical assessment of akathisia at entry
- •10. 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.
- •11. Subjects with hypothyroidism or hyperthyroidism (unless condition
- •has been stabilized with medications for at least the past 90 days)
- •and/or an abnormal result for free T4 at
- •screening/baseline.
- •12. Subjects who currently have clinically significant neurological,
- •hepatic, renal, metabolic, hematological, immunological, cardiovascular,
- •pulmonary, or gastrointestinal disorders such as any history of
- •myocardial infarction, congestive heart failure, HIV seropositive
- •status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
- •13. Subjects with IDDM (ie, any subjects using insulin)
- •14. Subjects with known ischemic heart disease or history of myocardial
- •infarction, congestive heart failure (whether controlled or uncontrolled),
- •angioplasty, stenting, or coronary artery bypass
- •15. Subjects with epilepsy or a history of seizures
- •16. Subjects with uncontrolled hypertension (DBP > 95 mmHg in any
- •position) or symptomatic hypotension, or orthostatic hypotension which
- •is defined as a decrease of = 30 mmHg in SBP
- •and/or a decrease of = 20 mmHg in DBP after at least 3 minutes
- •standing compared to the previous supine blood pressure, OR
- 另有 6 项未显示
研究者
相似试验
尚未招募
3 期
A Study to check the effect of Oral OPC-34712 asMaintenance Treatment in Adults with SchizophreniaCTRI/2013/05/003640Otsuka Pharmaceutical Development Commercialization Inc1,000
进行中（未招募）
不适用
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With SchizophreniaEUCTR2011-002514-37-SKOtsuka Pharmaceutical Development & Commercialization, Inc.1,000
进行中（未招募）
1 期
A Phase 3 Trial Investigating the Long-term Safety and Tolerability of OPC-34712 in the Treatment of Adults with Major Depressive DisorderMajor Depressive Disorder (MDD)MedDRA version: 14.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2011-001351-37-SKOtsuka Pharmaceutical Development & Commercialization, Inc.1,280
进行中（未招募）
1 期
A Phase 3 Trial Investigating the Long-term Safety and Tolerability of OPC-34712 in the Treatment of Adults with Major Depressive DisorderMajor Depressive Disorder (MDD)MedDRA version: 14.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873EUCTR2011-001351-37-HUOtsuka Pharmaceutical Development & Commercialization, Inc.3,000
进行中（未招募）
不适用
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With SchizophreniaEUCTR2011-002514-37-LVOtsuka Pharmaceutical Development & Commercialization, Inc.1,000