A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 246
- 主要终点
- Mean change from Baseline to EOT in total CDRS-R (raw) score
研究概览
简要总结
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
详细描述
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The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.
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The secondary efficacy endpoints include:
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Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
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Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score <29)
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Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
- Incidence of AEs
- Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
- Treatment discontinuation due to AEs
- Suicidality as assessed by the C-SSRS score
- Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged ≥7 to <18 years (at Screening Visit 1).
- •Provide assent (subject) and written informed consent (parent/legal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1).
- •Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2).
- •Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).
- •Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).
- •CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).
排除标准
- •are unable to swallow medications without difficulty
- •have known hypersensitivity to bupropion hydrobromide
- •are pregnant or planning to get pregnant or are lactating
- •Women of childbearing age unable to use at least one method of effective contraception for the duration of the study
- •Previous history of attempted suicide
- •are unable to understand and communicate effectively with parent, Investigator, and study coordinator
- •are at immediate risk of requiring hospitalization, in the Investigator's opinion
- •have current seizure disorder or history of seizures or head trauma
- •have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities
- •have ECG or physical examination abnormality at screening
- •have body weight less than the 3rd percentile or greater than the 97th percentile for age.
研究组 & 干预措施
bupropion hydrobromide
study drug
干预措施: bupropion hydrobromide (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from Baseline to EOT in total CDRS-R (raw) score
时间窗: Baseline and 2 years
Change from Baseline to EOT in total Children's Depression Rating Scale - Revised (CDRS-R). A higher score indicates a more profound state of depression. The interviewer rates 17 symptom areas; the symptom scores are summed to generate a total score. The total score ranges from 17 to 108.
次要结局
未报告次要终点