NCT00296517已完成3 期
Clinical Evaluation of 323U66 SR in Patients With Depression - Placebo-controlled, Double-blind, Comparative Study in Patients With Depression Who Did Not Respond Sufficiently to Selective Serotonin Re-uptake Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
研究概览
简要总结
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •[At the start of the pre-treatment phase]
- •Patients with a complication of glaucoma
- •Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding
- •Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure).
- •Patients who currently have or have a past history of the following disorders:
- •Anorexia nervosa (DSM-IV-TR 307.1)
- •Bulimia nervosa (DSM-IV-TR 307.51)
- •Patients with a history of manic episode
- •Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder
- •Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder)
- •Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and formal cognitive behaviour therapy within 5 weeks prior to the start of the pre-treatment phase
- •Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the pre-treatment phase
- •Patients who have received electroconvulsive therapy within 17 weeks prior to the start of the pre-treatment phase
- •Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the pre-treatment phase
- •Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
- •Female patients who are pregnant, possibly pregnant or are nursing, and those who want to become pregnant before 30 days after the last dose of the investigational product
- •Patients who have attempted suicide within 17 weeks prior to the start of the pre-treatment phase, or patients for whom the score of suicide-related item No. 3 of HAM-D is >=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator)
- •Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator)
- •Patients with a history of hypersensitivity to 323U66 and/or paroxetine
- •Patients with serious cerebral disease
- •Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia
- •Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder) The index of seriousness is Grade 3 of "Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc." (PAB/PSD No.80 in 1992).
- •Patients with a history or complication of cancer or malignant tumour.
- •Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain)
- •Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg
- •Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator)
- •[At the start of the treatment phase]
- •Patients whose compliance of paroxetine during the pretreatment phase is less than 70%.
- •Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia
- •Patients with systolic blood pressure of >=160 mmHg or diastolic blood pressure of >=100 mmHg
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
干预措施: Placebo (Drug)
Bupropion SR
Experimental
Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
干预措施: 323U66 (Bupropion Hydrochloride Sustained Release) (Drug)
结局指标
主要结局
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
时间窗: Baseline and Week 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
次要结局
- Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12(Baseline to Week 8 and Week 12)
- Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12(Week 12)
- Safety: Adverse Events by Organ System Class, Intensity, and Frequency(Baseline to Week 12)
- Hamilton Depression Scale (HAM-D 17 Items) Total Score(Week 8 and Week 12)
- Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12(Baseline to Week 8 and Week 12)
- Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12(Baseline to Week 8 and Week 12)
- Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.(Baseline to Week 8 and Week 12)
- Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12(Baseline to Week 8 and Week 12)
- Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12(Baseline to Week 8 and Week 12)
- Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12(Baseline to Weeks 1, 2, 3, 4, 8, and 12)
- Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12(Baseline to Week 8 and Week 12)
研究者
研究点 (1)
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