EUCTR2013-003038-34-SK进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression - A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 525
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 who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. If the patient is a minor at the time of consent, written consent should be obtained from a legally acceptable representative (guardian) in addition to the patient him/herself.
- •2) Outpatients aged 18 through 74 years at informed consent.
- •3) Patients with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (= 4 episodes of mood disturbance but < 8 episodes in the 12 months prior to screening), and without psychotic features (diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Text Revision [DSM-IV-TR] criteria and confirmed by the Mini International Neuropsychiatric Interview [MINI]).
- •4) Patients who have a history of at least one manic or mixed episode (preferably with confirmation by a reliable informant, such as a family member or caregiver)
- •5) Patients whose current major depressive episode is = 4 weeks and < 12 months in duration at screening.
- •6) Patients with a rater-administered MADRS total score of = 20 and a computer-administered MADRS total score of = 20 at both screening and baseline.
- •7) Patients with a YMRS total score of = 12 at both screening and baseline.
- •8) Patients with a negative pregnancy test at screening, when the patients are female and of childbearing potential.
- •9) Patients who agree to use appropriate contraception to prevent pregnancy in female patients and the female partners of patients, when the patients or their partners are of childbearing potential.
- •10) Patients whose dosage of the following concomitant drugs remains unchanged
- •for the specified duration as follows:
- •- The dose of oral hypoglycemic drugs or antihypertensive drugs remained unchanged for at least 30 days prior to screening.
- •- The dose of thyroid hormone (replacement therapy) remained unchanged for at least 90 days prior to screening.
- •- The dose of drugs for complications (other than the above-mentioned drugs) have been stable (within ± 25%) for at least 30 days prior to screening.
- •- The content of psychotherapy and cognitive behavioral therapy remained unchanged for at least 12 weeks prior to screening.
- •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 476
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1) Patients who were diagnosed as having an Axis I or Axis II disorder (DSM-IV-TR criteria) other than bipolar I disorder that is the primary focus of treatment within 3 months prior to screening.
- •2) Patients with a score of = 4 on the MADRS item 10 (suicidal thoughts) at screening or baseline.
- •3) Patients with a Yes” response to the Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) at
- •screening (within 6 months prior to screening) or baseline.
- •4) Patients with imminent risk of suicide or injury to self, others, or property.
- •5) Patients for whom diagnostic agreement (based on the Bipolarity Index) between the investigator and Bracket (Pennsylvania, the United States), the agency for computerized diagnosis, cannot be reached.
- •6) Patients with a history of non-response to 6-week trial of 3 or more antidepressants (with or without concomitant use of mood stabilizers) during the current episode.
- •7) Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
- •8) Patients who received monoamine oxidase (MAO) inhibitor within 21 days prior to screening.
- •9) Patients who received fluoxetine or a combination of olanzapine and fluoxetine within 28 days prior to screening.
- •10) Patients who received any depot antipsychotics (sustained-release formulation) within 90 days prior to screening.
- •11) Patients who received clozapine within 120 days prior to screening.
- •12) Patients who received electroconvulsive therapy within 90 days prior to screening.
- •13) Patients with a = 25% reduction in the MADRS total score between screening and baseline.
- •14) Patients with a history of HIV seropositivity.
- •15) Patients with a history of alcohol/drug abuse (DSM-IV-TR criteria) within 3 months prior to screening or of alcohol/drug dependence (DSM-IV-TR criteria) within 12 months prior to screening. Exceptions include caffeine or nicotine
- •abuse/dependency.
- •16) Patients with a history of hypersensitivity (eg, drug-induced anaphylaxis, rash, urticaria, or other allergic reactions) to more than one distinct chemical class of drug.
- •17) Patients with previous or existing clinically significant complications, such as serious nervous system, endocrine system (eg, type I diabetes mellitus), hepatic, renal, hematological, respiratory, cardiovascular (eg, unstable angina, congestive
- •heart failure), gastrointestinal, urological, or other diseases. Patients who have a history of any of such diseases and who are considered ineligible for the study by the investigator.
- •18) Patients with acute hepatitis, severe chronic hepatitis or marked hepatic dysfunction. When the hepatitis screening test is positive, the investigator should evaluate carefully patient eligibility on the basis of his or her medical history or other laboratory data.
- •19) Patients with a gastrointestinal disease or a surgical history that may affect drug absorption, distribution, metabolism, or excretion.
- •20) Patients with any chronic organic disease of the central nervous system (ie, tumor, inflammation, convulsive seizure, vascular disorders, Parkinson’s disease, Alzheimer’s disease or other type of dementia, myasthenia gravis, or other
- •degenerative diseases) .
- •21) Patients with any mental retardation or persistent neurological findings due to serious head injury.
- •22) Patients with a BMI of = 18 kg/m2 or
研究者
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