EUCTR2011-002334-39-BG进行中（未招募）1 期
A Double-blind, Placebo-Controlled Evaluation of the Safety andEfficacy of Cariprazine in Patients With Bipolar Depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 584
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. 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 patients 18 to 65 years of age, inclusive
- •3. Currently meet the DSM-IV-TR criteria for bipolar I disorder without psychotic
- •features confirmed by the administration of the Structured Clinical Interview (SCID),
- •with a current major depressive episode of at least 4 weeks and not exceeding
- •12 months in duration
- •4. A verified previous manic or mixed episode. Verification must include one of the following sources;
- •? Hospital records
- •? Medical Records
- •? Patient report corroborated by:
- •- family member, caretaker, or previous or current treating clinician with
- •confirmation of treatment with an anti-manic or antipsychotic medication
- •- confirmation of treatment with an anti-manic or antipsychotic medication
- •5. 17-item Hamilton Depression Rating Scale (HAMD-17) total score = 20
- •6. HAMD-17 item 1 score = 2
- •7. Clinical Global Impressions–Severity (CGI-S) score = 4
- •8. Negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test (women of
- •childbearing potential only)
- •9. Normal physical examination findings, clinical laboratory test results, and
- •electrocardiogram (ECG) results or abnormal results that are judged not clinically
- •significant by the PI and documented as such in the eCRF
- •10. Body mass index between 18 and 40, inclusive
- •Inclusion criteria to be assessed at Visit 2 (Baseline)
- •11. Continue to meet Visit 1 inclusion criteria
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Young Mania Rating Scale (YMRS) total score > 10
- •2. Four or more episodes of a mood disturbance (depression, mania, hypomania, or
- •mixed state) within the 12 months before Visit 1
- •3. Principal DSM-IV-TR–based diagnosis of an axis I disorder other than bipolar
- •disorder or any axis I disorder other than bipolar disorder 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)
- •4. History of meeting DSM-IV-TR criteria for:
- •a. Dementia, amnesic, or other cognitive disorder
- •b. Schizophrenia, schizoaffective, or other psychotic disorder
- •c. Mental retardation
- •5. 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
- •6. 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
- •7. Positive result on blood alcohol test or urine drug screen for methadone,
- •phencyclidine, amphetamines, or cocaine. (Patients with a positive urine drug screen
- •for cannabinoids, barbiturates, opiates, or benzodiazepines may be allowed in the
- •study provided that a discussion with the Medical Monitor has occurred and the use
- •of such products can be discontinued before participation in the study; medically
- •appropriate episodic use [up to 3 days] of narcotic analgesics for acute medical
- •indications is allowed during the study; discussion with Medical Monitor is
- •recommended).
- •8. History of intolerance or hypersensitivity to other drugs of the same class as
- •cariprazine or to rescue medications (see Section 9.4.7)
- •9. History of nonresponse in the current depressive episode to 2 or more adequate
- •treatment trials (at least 6 weeks at an adequate dose based on package insert
- •recommendations) with Symbyax (fluoxetine and olanzapine), quetiapine (including
- •monotherapy), lithium (including monotherapy) or a mood stabilizer (lithium,
- •valproate, lamotrigine, carbamazepine, or oxcarbazepine) in combination with an
- •antidepressant. Aripirazole was found ineffective for bipolar depression in 2 large
- •controlled trials. It should not be considered as a treatment failure for the history of
- •nonresponse exclusion criteria.
- •10. At imminent risk of injuring self or others or causing significant damage to property,
- •as judged by the PI
- •11. 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)
- •? HAMD-17 Item 3 score = 3
- •? MADRS Item 10 score = 4
- •Treatment-Related Criteria:
- •12. Electroconvulsive therapy in the 3 months before Visit 1
- •13. Previous lack of response to electroconvulsive therapy
- •14. Treatment with a depot neuroleptic within 1 treatment cycle before Visit 1
- •15. Treatment with clozapine in the past 2 years (exceptions: episodic use of clozapine at
- •doses = 150 mg/day for the treatment of insomnia)
- •16. Requiring concomitant treatment with any of the prohibited medications,
- •supplements, or herbal products listed in Appendix II, including any psychotropic
- 另有 2 项未显示
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