NCT00330616已完成2 期
Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
研究概览
简要总结
This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Target disease: Patients diagnosed as having the following primary disease and current major depressive episode for at least 8 weeks on the basis of DSM-IV-TR criteria.
- •Major Depressive Disorder, Single Episode (296.2x) (excluding those with psychotic features)
- •Major Depressive Disorder, Recurrent (296.3x). (excluding those with psychotic features)
- •HAM-D (17 items) total score >/=
- •Age: >/=65 years old (at the time of informed consent)
- •Gender: Male or female.
- •Inpatient or outpatient status: Either
- •Informed consent: The subject himself/herself must give written informed consent.
排除标准
- •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 standardized cognitive behaviour therapy within 12 weeks prior to the start of the 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 treatment phase
- •Patients who have received electroconvulsive therapy within 24 weeks prior to the start of the treatment phase
- •Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the treatment phase
- •Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase
- •Patients who have attempted suicide within 24 weeks prior to the start of the treatment phase, or patients for whom the score of the suicide-related item 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
- •Patients with serious cerebral disease
- •Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) assesses the subject is predisposed 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 who have a history or complicated carcinoma 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 at the start of the Treatment Period
- •Patients diagnosed with dementia
- •Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator).
结局指标
主要结局
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
时间窗: Baseline and Week 8
The Hamilton Rating Scale for Depression (HAM D) 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 53 (severely ill).
次要结局
- Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8(Baseline and Week 8)
- Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4(Week 4)
- Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8(Week 8)
- Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4(Week 4)
- Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8(Week 8)
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4(Baseline and Week 4)
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8(Baseline and Week 8)
- Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4(Baseline and Week 4)
- Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8(Baseline and Week 8)
- Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8(Week 4 and Week 8)
- Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8(Week 4 and Week 8)
- Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8(Baseline, Weeks 1, 2, 3, 4, 8)
- Adverse Events (>=5% Incidence)(Baseline through Week 8)
- Serious Adverse Events(Baseline through Week 8)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
3 期
Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake InhibitorsDepressive DisorderNCT00296517GlaxoSmithKline325
已完成
4 期
Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive DisorderMajor Depressive DisorderNCT01541475Ewha Womans University60
终止
4 期
Bupropion for Depression in ESRD Patients on HemodialysisMajor DepressionEnd Stage Renal DiseaseNCT02238977University of Arkansas1
已完成
1 期
Buprenorphine Dose Escalation Trial for Treatment of Non-Dependent Opiate Users - 2Substance-Related DisordersOpioid-Related DisordersNCT00015041National Institute on Drug Abuse (NIDA)
已完成
不适用
Effects of Bupropion in DepressionDepressionNCT02104128University of Oxford80