NCT04979910已完成2 期
An Experimental Therapeutics Study of a Monoclonal Antibody Against Interleukin 17A in Patients With Treatment-Resistant Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants Who Dropped-out
研究概览
简要总结
The proposed study aims to test ixekizumab, a monoclonal antibody (mAb) against interleukin 17A (IL-17A), in patients with treatment-resistant depression (TRD).
详细描述
In the proposed study n=20 adult individuals with TRD will be treated with ixekizumab for 4 weeks. Participants will complete screening procedures, body fluid analyses and brain imaging before and after treatment with ixekizumab.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (and assent when applicable) obtained from subject;
- •Ability for subject to comply with the requirements of the study as determined by the PI;
- •Men and women, age 18-70 years;
- •Participants must meet DSM-5 criteria for Major Depressive Disorder [MDD]) in a current major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV);
- •Participants have had ≥ 2 adequate trials of antidepressants/augmentation strategies during current episode. (Refer to ATRQ Guidelines for Completion for guidelines on dose/duration required for a trial to be considered adequate.);
- •Patients must be on a stable dose of antidepressant medication for >4 weeks prior to randomization;
- •Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score ≥ 14
- •If female of childbearing potential, must agree to use of a medically accepted form of contraception, or else agree to abstinence until 6 months after the last dose of study drug.
- •Male patients, if heterosexually active with a partner who is female of childbearing potential, pregnant, or breastfeeding, must agree to barrier contraception for the treatment period and for at least 6 months after the last dose of study drug. Female partners of male participants must use at least one form of highly effective contraception starting at least one cycle prior to male patient study drug initiation until 6 months after the last dose of study drug.
排除标准
- •A primary psychiatric diagnosis other than MDD as defined by DSM-5; [comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and posttraumatic stress disorder (PTSD) are allowed];
- •Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder;
- •Diagnosis of a major neurocognitive disorder;
- •Meets criteria for a moderate or severe substance use disorder within the past 6 months, with the exception of nicotine use disorder;
- •The patient is pregnant or breastfeeding;
- •Any contraindication to MRI or gadolinium including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, inability to lie still for 1 hour or more, any known allergy to gadolinium;
- •Positive urine toxicology screen for illicit drugs at the time of screening;
- •Serious and imminent risk of self-harm or violence as determined by the PI;
- •History of suicide attempt in the past 2 years or screening CSSRS Ideation Score >2 in the past month;
- •Clinically significant abnormalities of laboratory tests or physical examination;
- •Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
- •Presence of TB as assessed by Quantiferon Gold test at screening;
- •Concomitant treatments with other biologics or other immune-suppressant agents; PRN use of NSAIDs is permissible;
- •Female participants who are pregnant, breastfeeding, or may become pregnant, or unwilling to practice birth control during participation in the study or the 6 months following;
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
Ixekizumab
Experimental
Ixekizumab 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2 and 4 via subcutaneous route.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Number of Participants Who Dropped-out
时间窗: 6 weeks
The safety and feasibility of using ixekizumab in patients with TRD will be assessed by the completion of treatment measured as the receipt of all three Ixekizumab injections (160 mg at week 0, 80 mg at weeks 2 and 4). Drop-out rates will be calculated.
Number of Anticipated and Unanticipated Adverse Events
时间窗: 6 weeks
The incidence and frequency of all anticipated and unanticipated serious and non-serious adverse events
次要结局
- Change in Quick Inventory of Depressive Symptomatology, Self-Report [QIDS-SR] Score(Baseline and 6 weeks)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS)(Up to Week 6)
- Change in Montgomery-Åsberg Depression Rating Scale Score - Response Rate(Baseline and 6 weeks)
- Change in Montgomery-Åsberg Depression Rating Scale Score - Remission Rate(Baseline and 6 weeks)
- Change in Temporal Experience of Pleasure Scale(Baseline and 6 weeks)
- Change in Clinical Global Impression Scale(Baseline and 6 weeks)
- Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline and 6 weeks)
- Change in The Hamilton Anxiety Rating Scale (HAM-A)(Baseline and 6 weeks)
研究者
James Murrough
Associate Professor of Psychiatry and Neuroscience
Icahn School of Medicine at Mount Sinai
研究点 (1)
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