EUCTR2009-017852-28-DE进行中（未招募）不适用
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 versus Placebo in Patients with DSM-IVTR Schizophrenia - HBBM(a)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 880
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] Patients are male or female, 18 to 65 years of age (inclusive) at study
- •entry, with a diagnosis of schizophrenia as defined in the Diagnostic
- •and Statistical Manual of Mental Disorders, Fourth Edition, Text
- •Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic,
- •295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed
- •by the Structured Clinical Interview for DSM-IV-TR (SCID).
- •[2] Female patients of childbearing potential must test negative for
- •pregnancy at Visit 1 and agree to use a single, effective, medically
- •acceptable method of birth control, specifically: an oral contraceptive
- •combined pill; an implantable contraceptive; an injectable
- •contraceptive; a contraceptive patch (for women <198 pounds or 90
- •Kg); or an intrauterine device/system. The double-barrier method, as
- •defined by two physical barriers such as a condom, diaphragm, or
- •cervical occlusive cap, coupled with an additional barrier such as
- •spermicidal foam, gel, film, cream or suppository, is also an acceptable
- •method of birth control. Patients having undergone a hysterectomy or
- •bilateral oophorectomy or other form of female sterilization, or
- •patients having been medically confirmed to be post-menopausal,
- •would not require any method of contraception.
- •[3] At Visits 1 and 2, patients must meet a Clinical Global Impression-
- •Severity (CGI-S) rating =4 (moderately ill) and must be patients in
- •whom a modification of antipsychotic medication, or the initiation of
- •antipsychotic medication, is acutely indicated, in the opinion of the
- •investigator.
- •[4] Patients must be willing to participate in a minimum of 3 weeks of
- •inpatient hospitalization, and this must be appropriate for the patient in
- •the clinical judgment of the investigator.
- •[5] Patients must have been suffering from schizophrenia for at least 1
- •year prior to Visit 1, as determined from onset of illness.
- •[6] At Visit 1, patients who are not antipsychotic treatment-naive must
- •have a lifetime history of at least one hospitalization for the treatment
- •of schizophrenia, not including hospitalization required for this study.
- •Patients who are antipsychotic treatment-naive may enter the study,
- •even without a history of hospitalization.
- •[7] At Visit 1, patients who are not antipsychotic treatment-naïve must
- •have a history of at least one episode of illness exacerbation requiring
- •an intensification of treatment intervention or care in the last 2 years,
- •not including the present episode of illness. Patients who are
- •antipsychotic treatment-naive may enter the study, even without a past
- •history of illness exacerbation and intensification of treatment in the
- •last 2 years.
- •[8] At Visit 1, patients also must have experienced an exacerbation of
- •their illness within the 2 weeks prior to Visit 1, leading to an
- •intensification of psychiatric care in the opinion of the investigator.
- •Examples of intensification of care include, but are not limited to:
- •inpatient hospitalization, day/partial hospitalization, outpatient crisis
- •management, or psychiatric treatment in an emergency room. If
- •exacerbation occurs in patients who are presently hospitalized, the
- •patient must not have been hospitalized longer than 60 days prior to
- •[9] Patients must be considered reliable and have a level of understanding
- 另有 4 项未显示
排除标准
- •[13] Have any other current Axis I psychiatric diagnoses (as defined in
- •DSM-IV-TR) in addition to schizophrenia.
- •[16] Patients for whom treatment with risperidone, LY2140023, or placebo,
- •as specified in this protocol, is relatively or absolutely clinically
- •contraindicated.
- •[17] Patients who have received treatment with clozapine at doses greater
- •than 200 mg daily within 12 months prior to Visit 1, or who have
- •received any clozapine at all during the month before Visit 1.
- •[21] Patients who require concomitant treatment with any other medication
- •with primary central nervous system activity, other than those allowed
- •as specified in Section 9.8 and Attachment HBBM.3, or with any other
- •medication specifically excluded in Protocol Attachment HBBM.3.
- •[22] Patients currently receiving treatment (within 1 dosing interval,
- •minimum of 4 weeks, prior to Visit 1) with a depot formulation of an
- •antipsychotic medication.
- •[23] Patients have answered ‘yes’ to either Question 4 (Active Suicidal
- •Ideation with Some Intent to Act, Without Specific Plan) or Question 5
- •(Active Suicidal Ideation with Specific Plan and Intent) on the
- •Suicidal Ideation portion of the C–SSRS, or answer yes to any of
- •the suicide-related behaviors (actual attempt, interrupted attempt,
- •aborted attempt, preparatory act or behavior) on the Suicidal
- •Behavior portion of the C–SSRS; and the ideation or behavior
- •occurred within the past month.
- •[26] Female patients who are pregnant, nursing, or who intend to become
- •pregnant within 30 days of completing the study.
- •[27] Have known, uncorrected, narrow-angle glaucoma.
- •[28] Have a history of one or more seizures, except for those who
- •experienced a single simple febrile seizure between ages 6 months and
- •5 years (a single simple febrile seizure is defined as lacking focality
- •and lasting less than 15 minutes, not associated with a central nervous
- •system (CNS) infection or severe metabolic disturbance).
- •[29] Patients are excluded if they have a first-degree relative (that is,
- •biological father, mother, brother, sister, or child) with history of
- •idiopathic epilepsy.
- •[30] Within 1 year of study enrollment, patients have a history of CNS
- •infection, uncontrolled migraine, transient ischemic attack (TIA), or
- •head trauma with loss of consciousness or a post-concussive
- •[31] Patients are excluded if they have a lifetime history of any of the
- •o head trauma, stroke, or CNS infection with persistent neurological
- •deficit (focal or diffuse);
- •o brain surgery;
- •o an EEG with paroxysmal (epileptiform) activity, for example, one
- •that demonstrates 3 or more focal sharp or spike waves, any sharp
- •and slow wave complex, or any epileptiform discharge that is
- •rhythmic, sustained, or generalized; or as locally defined; or
- •o brain structural lesion, including developmental abnormalities, as
- •determined by examination or previous neuroimaging studies that
- •are consistent with a diagnosable neurological disease or
- •[32] Patients who have had electroconvulsive therapy (ECT) within 3
- •months of Visit 1 or who will have ECT at any time during the study.
- 另有 6 项未显示
研究者
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