EUCTR2008-006492-71-SK进行中（未招募）1 期
A double-blind, efficacy and safety study of duloxetine versus placebo in the treatment of children and adolescents with major depressive disorder
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 336
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
- •Patients are eligible to be included in the study only if they meet all of the following
- •1. Outpatient male or female aged 7 to 17 years, inclusive, at the time of signing the informed consent/assent document and diagnosed with MDD as defined by the DSM-IV-TR and supported by the MINIKID.
- •2. Diagnosis of moderate or greater severity of MDD as determined by CDRS-R with a total score =40 at Visit 1, Visit 2, and Visit 3 and a CGI-Severity rating of =4 at Visit 1, Visit 2, and Visit 3.
- •3. Female patients must test negative for pregnancy during screening.
- •Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study. Examples of reliable birth control methods include the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical
- •caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices); partner with vasectomy; or abstinence.
- •4. Patient’s parent/legal representative and patient, if capable, are judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
- •5. Patient’s parent/legal representative and patient, if capable, must have a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
- •6. Patients must be capable of swallowing study drug whole (without opening the capsule, crushing, dissolving, dividing, etc.). It is anticipated the patients will need to swallow up to 6 capsules per day.
- •7. Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •8. Are the children of investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •9. Are the children of Lilly employees or employees of the designated Clinical Research Organisation assisting with the conduct of the study.
- •10. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •11. Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator.
- •In addition, patients with an Axis II disorder (eg, borderline personality disorder) will be excluded if, in the judgment of the investigator, the Axis II disorder would interfere significantly with protocol compliance.
- •12. Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
- •13. Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment (other than those disorders listed in Exclusion Criteria 11 and 12).
- •14. Have 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder.
- •15. Have a significant suicide attempt within 1 year of Visit 1 or are currently at risk of suicide in the opinion of the investigator.
- •16. Have a weight less than 20 kg at any Screening Phase visit.
- •17. Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode.
- •In addition, patients who have had a lack of response of their current depressive episode to a clinically appropriate dose of fluoxetine (ie, at least 20 mg/day for 4 weeks) will be excluded. Patients who have had a lack of response of their current depressive episode to duloxetine, as judged by the investigator, will be excluded.
- •18. Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to Visit 1. Patients who require a change to psychotherapy (start, stop, or change in type, intensity, or frequency) during study Period II will be excluded.
- •19. Have a history of seizure disorder (other than febrile seizures).
- •20. Have a history of electroconvulsive therapy (ECT) within 1 year of Visit 1.
- •21. Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of Visit 3; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug.
- •22. Have previously enrolled (ie, received study drug), completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine.
- •23. Have a positive urine drug screen for any substances of abuse or excluded medication. Note: If the patient has a positive urine drug screen at Visit 1 for an excluded medication that may not have had an adequate washout period, a re-test may be performed and evaluated prior to Visit 3.
- •24. Are taking any excluded medications (eg, stimulants or other antidepressants) that cannot be discontinued by Visit 2.
- •25. Have known hypersensitivity to duloxetine, fluoxetine, or their i
研究者
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