EUCTR2011-005179-18-SK进行中（未招募）不适用
A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) asAdjunctive Therapy In Major Depressive Disorder.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 810
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
- •To be eligible to participate in the study, patients must meet the following criteria:
- •1. Written informed consent, signed or thumbprinted (only if allowed by local
- •regulations), obtained from the patient before the initiation of any study-specific
- •2. Male or female outpatients 18 to 65 years of age, inclusive
- •3. Currently meet the DSM-IV-TR criteria for MDD without psychotic features based
- •on the Structured Clinical Interview for Diagnostic Statistic Manual of Mental Health
- •Disorders, Fourth Edition (SCID), with a current major depressive episode of at least
- •8 weeks and not exceeding 24 months in duration at Visit 1
- •4. Ongoing inadequate response to protocol allowed ADT (bupropion, citalopram,
- •desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or
- •vilazodone) administered at adequate dose and duration in accordance with the
- •respective package insert, documented in the Antidepressant Treatment History Form
- •(ATHF) with a resistance rating of = 3 and a global confidence score of = 3
- •5. Montgomery-Asberg Depression Rating Scale (MADRS) total score = 22 at both
- •Screening (Visit 1) and Baseline (Visit 2)
- •6. Normal physical examination findings, clinical laboratory results, and
- •electrocardiogram (ECG) results from Screening (Visit 1) or abnormal findings
- •judged not clinically significant by the PI and documented as such in the eCRF
- •7. Body mass index between 18 and 40, inclusive
- •8. If female of child bearing potential, have a negative serum ß-human chorionic
- •gonadotropin (ß-hCG]) pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 810
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Psychiatric Criteria:
- •1. Principal DSM-IV-TR–based diagnosis of an axis I disorder, other than MDD, or
- •any axis I disorder other than MDD that was the primary focus of treatment within
- •6 months before Visit 1 (secondary diagnoses of comorbid generalized anxiety
- •disorder, social anxiety disorder, or specific phobias are acceptable)
- •2. History of meeting DSM-IV-TR criteria for:
- •a. Any depressive episode with psychotic or catatonic features
- •b. Any manic, hypomanic or mixed episode, including bipolar disorder and
- •substance-induced (eg, antidepressant-induced) manic, hypomanic or mixed
- •c. Schizophrenia, schizoaffective, or other psychotic disorder
- •d. Panic disorder, with or without agoraphobia
- •e. Obsessive-Compulsive disorder
- •f. Bulimia or Anorexia Nervosa
- •g. Dementia, amnesic, or other cognitive disorder
- •h. Mental retardation
- •3. Meeting full DSM-IV-TR criteria for MDD with seasonal pattern” AND the
- •patient’s season of remission would occur during the study.
- •4. DSM-IV-TR–based diagnosis of borderline or antisocial personality disorder or other
- •axis II disorder of sufficient severity to interfere with participation in this study
- •5. History of meeting DSM-IV-TR criteria for alcohol or substance abuse or dependence
- •(other than nicotine or caffeine) within the 6 months before Visit 1
- •6. Positive result on blood alcohol test or for any prohibited medication on the urine
- •drug screen with the following stipulations:
- •? Patients with a positive urine drug screen for cannabinoids, barbiturates, opiates,
- •amphetamines, or benzodiazepines may be allowed in the study provided that the
- •drug was used for a legitimate medical purpose and the use of such products can
- •be discontinued (documented by a negative repeat test) before participation
- •beyond screening
- •? Medically appropriate episodic use (up to 3 days) of narcotic analgesics for acute
- •medical indications is allowed
- •? Discussion with Medical Monitor is recommended in any potential exception
- •listed above
- •? Positive results for methadone, phencyclidine, and cocaine are exclusionary with
- •no exceptions
- •7. Suicide risk, as determined by meeting any of the following criteria:
- •? A suicide attempt within the past year
- •? Significant risk, as judged by the PI, based on the psychiatric interview or
- •information collected in the Columbia–Suicide Severity Rating Scale (C-SSRS) at
- •Visit 1 or Visit 2
- •? MADRS Item 10 score = 5 at Visit 1 or Visit 2
- •8. At imminent risk of injuring self or others or causing significant damage to property,
- •as judged by the PI
- •9. Requires hospitalization
- •Treatment-Related Criteria:
- •10. Treatment refractory depression as defined by:
- •? Failure to respond (< 50% reduction in depressive symptoms) to = 3 ADTs
- •given at adequate dose (as defined by the ADT package insert) and duration of
- •> 6 weeks during the present episode
- •? History of inadequate response to ECT, a monoamine oxidase inhibitor, or
- •adjunctive treatment with an antipsychotic
- 另有 6 项未显示
研究者
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