A Single Center, Open Label Study Assessing the Feasibility, Safety and Therapeutic Effect of Minocycline in Adult Patients With Diagnosis of Unipolar Depression.
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Depression symptoms
研究概览
简要总结
A single center, open label study assessing the feasibility, safety and therapeutic effect of Minocycline in adult patients with diagnosis of unipolar depression. Up to 30 patients diagnosed with unipolar depression that are in a current depressive episode. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 68 years of age, and have HDRS-21≥20. All subjects will continue to take their treatment with antidepressant medications for the duration of the study. All subjects are prescribed minocycline 200 mg/day orally (2X100 mg) for the first 3 days. than, all subjects are prescribed minocycline 400 mg/day orally (2X200 mg) from day 4 until termination visit (day 35). The primary objective of this study is to assess the therapeutic effect of Minocycline in unipolar depression.
The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of Minocycline in unipolar depression.
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 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.
- •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 opioids, nicotine and caffeine).
- •All antidepressant medications, must have been in stable dosage for at least 3 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
- •Subjects who were taking a known contraindication to minocycline treatment.
- •Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
- •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 or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.(if using oral contraceptives, during the minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding
- •Patients with severe hepatic or renal insufficiency.
研究组 & 干预措施
Minocycline
Minocycline 200 mg/day (2X100 mg) from day 1 to day 3 and Minocycline 400 mg/day (2X200mg) form day 4 until termination visit (day 35)
干预措施: Minocycline (Drug)
结局指标
主要结局
Depression symptoms
时间窗: from baseline (day 1) to termination (day 35)
The change in Scale for Depression (HDRS-21) score from baseline to the end of the study (visit 4 - day 35) where response is defined as ≤50% reduction in HDRS-21 score from baseline.
次要结局
- Depression symptoms - CGI(from baseline (day 1) untill termination visit (day 35))
- depression symptoms - (QIDS-SR)(from baseline (day 1) untill termination visit (day 35))
- depression symptoms - HDRS-21(from baseline (day 1) untill termination visit (day 35))
- Safety(frpm baseline (day 1) untill the termination visit (day 35))