NCT01311570Unknown1 期
A Single Center, Open Label, Dose-titration, add-on Study Assessing the Feasibility, Safety and Therapeutic Effect of Buprenorphine in Adult Patients With Diagnosis of Major Depression.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
研究概览
简要总结
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients and inpatients
- •Men and women 18-68 years of age.
- •Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥
- •Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
- •The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
- •If currently taking Benzodiazepines, the patient must be clinically appropriate to discontinue treatment with those agents, and able to tolerate no benzodiazepines during the study period.
- •Capable and willing to provide informed consent
- •Able to adhere to the treatment schedule.
排除标准
- •Depression secondary to a general medical condition.
- •History of substance abuse or dependence within the past 6 month (except nicotine and caffeine).
- •All antidepressant medications, must have been in stable dosage for at least 6 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
- •Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
- •Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
- •Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- •Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the screening visit
- •Use of a CYP3A4 Inhibitors and CYP3A4 Inducers within 2 weeks of screening visit.
- •Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
- •Known or suspected pregnancy
- •Women who are breast-feeding
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
- •Patients with severe respiratory insufficiency or asthma - anticipation require examination of pulmonologist.
- •Patients with severe hepatic or renal insufficiency.
- •Patients with history of head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis- anticipation require examination of neurologist.
研究组 & 干预措施
Buprenorphine
Experimental
干预措施: Buprenorphine (Drug)
结局指标
主要结局
The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.
时间窗: from baseline to day 42 [end of Buprenorphine treatment]
次要结局
- The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.(from baseline to day 42 [end of Buprenorphine treatment])
研究者
研究点 (1)
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