CTRI/2010/091/001409招募中3 期
A multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate prevention of relapse in patients with schizophrenia receiving either flexible dose iloperidone (Fanapt?) or placebo in long-term use (up to 26 weeks) followed by up to 52 weeks of open label extension.
ovartis Healthcare Private Limited0 个研究点目标入组 710 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 710
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
入选标准
- •Patients will be males or females, 18 through 65 years of age inclusive.
- •- Patients will have a clear diagnosis of schizophrenia according to DSM-IV criteria for at least 1 year. This includes DSM-IV diagnoses of schizophrenia (i.e., 295) with suffixes 10 (disorganized), 20 (catatonic), 30 (paranoid), 60 (residual), or 90 (undifferentiated).
- •- Patients will be in need of ongoing psychiatric treatment and must have a documented reason why a change in treatment is warranted, which might reasonably be expected to possibly lead to a clinical improvement. This will be recorded as either:
- •- Insufficient efficacy (i.e., not fully in remission or experiencing residual symptoms) and / or Tolerability/safety concerns (e.g. weight gain, extrapyramidal symptoms, etc.)
- •- At the screening visit patients will have a PANSS score of no more than 100 and a CGI of no more than 5 (i.e. must not be severely ill or worse).
- •- History of at least 2 prior episodes of relapse or impending relapse in the 2 years preceding the screening visit (i.e., verifiable in source documents by report of health professional or patient?s caregiver or relative).
排除标准
- •- Patients who meet the DSM-IV criteria for schizophreniform disorder (295.40) and schizoaffective (295.70) will be excluded.
- •- Patients with active symptoms of any other primary psychiatric diagnosis (Axis I) or prominent Axis II disorder which would interfere with compliance to the protocol.
- •- Patients who have a positive urine drug screen (at the screening visit) for amphetamines, cocaine, phencyclidine (PCP), or opiates will be excluded. If opiates are positive at screening and clearly due to the use of pain killing medication, the patient may be rescreened after the medication has been discontinued and enrolled in the study if urine drug screen is negative.
- •- Otherwise patients positive for opiates will be disqualified from any future participation in the study.
- •- Patients who have been hospitalized due to suicidal ideation or suicidal behavior; or patients considered to have serious suicidal ideation or suicidal behavior within the 6 months prior to the screening visit; or patients having active suicidal ideation or behavior at the screening visit as determined by the Columbia Suicide-Severity Rating Scale (C-SSRS).
- •- Patients currently having clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection, that would pose a risk to the patient if they were to participate in the study or that might confound the results of the study. Patients with known human immunodeficiency virus (HIV) seropositivity. However, unless clinically indicated, HIV testing will not be performed.
- •- Treatment naïve, first episode patients.
- •- Patients taking iloperidone at the screening visit.
- •- Patients with known hypersensitivity to drugs chemically related to benzisoxazoles.
研究者
相似试验
进行中（未招募）
不适用
A study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myelomaMultiple Myeloma (MM), relapsed or relapsed-and-refractoryMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-015507-52-FIovartis Pharma Services AG750
进行中（未招募）
1 期
A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsEUCTR2016-002033-30-BEeuroDerm Ltd.240
进行中（未招募）
1 期
A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myelomaEUCTR2009-015507-52-DEovartis Pharma Services AG750
进行中（未招募）
1 期
A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsSubjects with Parkinson’s Disease with motor fluctuationsMedDRA version: 19.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002033-30-ESeuroDerm Ltd.150
进行中（未招募）
1 期
A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsSubjects with Parkinson’s Disease with motor fluctuationsMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002033-30-ITEURODERM LTD.240