A randomised, double-blind, placebo-controlled, hybrid parallel arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder

niversity of Auckland0 个研究点目标入组 72 人开始时间: 2022年6月21日最近更新: 2024年4月8日

适应症

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 72

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 55 Years（—）
性别: All

入选标准

•Inclusion criteria for participants with depression:
•- Provision of signed and dated informed consent form
•- Stated willingness to comply with all study procedures and availability for the duration of the study
•- Male or female, aged 18 to 55 years.
•- Diagnosis of MDD as per the Diagnostic and Statistical Manual 5 criteria for MDD
•- Experiencing significant depressive symptoms, as indicated by a score greater than or equal to 18 on the MADRS
•- Receiving treatment with an antidepressant agent (not greater than Stage II antidepressant resistance as defined by the Thase and Rush treatment-resistant depression staging method)
•- Clinically stable for at least four weeks
•- hsCRP levels either greater than or equal to 3 mg/L, or less than or equal to 1 mg/L
•- Ability to take oral medication and be willing to adhere to the dosing regimen
•- Agreement to adhere to Lifestyle Considerations throughout study duration (participants will be asked to abstain from alcohol and drugs for 24 hours before the start of each MRI and EEG session, and have a plan with their doctor to stay on the same antidepressant for at least 12 weeks).
•Inclusion criteria for healthy controls:
•- Provision of signed and dated informed consent form
•- Stated willingness to comply with all study procedures and availability for the duration of the study
•- Male or female aged 18 to 55 years
•-hsCRP levels less than or equal to 1 mg/L
•- Agreement to adhere to Lifestyle Considerations throughout study duration (healthy participants will be asked to abstain from alcohol and drugs for 24 hours before the start of each MRI and EEG session)

排除标准

•Exclusion criteria for participants with depression:
•- Current use of prescription opioid analgesics, psychostimulants, dopamine agonists
•- Current use of any opioid-based drugs recreationally
•- Any current or past bipolar or psychiatric disorder or psychotic features (other psychiatric conditions such as anxiety will be allowed for individuals with MDD, provided they are not the primary source of the participant’s depressive symptomatology)
•- Acute risk of suicide
•- Any known neurological disorders or neurodegenerative condition
•- Acute infectious pathology, or chronic or acute inflammatory diseases that, in the judgement of the investigators, interferes with study measures or procedures
•- Any clinically significant medical conditions, e.g., renal, hepatic, or cardiovascular conditions, uncontrolled thyroid dysfunction, metabolic disorders, cancer, seizure disorders
•- Uncontrolled autoimmune diseases or severe chronic pain
•- Or any other condition that, in the judgement of the investigators, interferes with study measures or procedures
•- Long-term, frequent, anti-inflammatory or immunosuppressive therapy
•- Contraindications to MRI or blood tests, including those who refuse to be informed of an incidental finding
•- Women who are pregnant or breastfeeding, or women of child-bearing age who are not on a medically acceptable form of contraception
•- Substance use disorders within the previous 12 months
•- Any allergy or intolerance to naltrexone
•Exclusion criteria for healthy controls:
•- Current use of any medication other than contraception
•- Current use of any opioid-based drugs recreationally
•- Any current or past psychiatric conditions
•- Any known neurological disorders or neurodegenerative condition
•- Acute infectious pathology, or chronic or acute inflammatory diseases
•- Any clinically significant medical conditions, e.g., renal, hepatic, or cardiovascular conditions, uncontrolled thyroid dysfunction, metabolic disorders, history of cancer, seizure disorders
•- Autoimmune diseases or chronic pain
•- Long-term anti-inflammatory or immunosuppressive therapy
•- Contra-indications to MRI or blood tests, including those who refuse to be informed of an incidental finding.
•- Women who are on hormone suppressants.
•- Women who are pregnant or breastfeeding

研究者

发起方

niversity of Auckland

相似试验

进行中（未招募）

1 期

To see how the medication MED2005 works (i.e. causes an erection) when applied to the penis by male volunteers who normally are unable to obtain an erectioThis study investigates a drug intended for the treatment of male patients self-diagnosed with Erectile DysfunctionMedDRA version: 18.1Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disorders

EUCTR2014-005571-89-PLFutura Medical Developments Ltd.192

进行中（未招募）

不适用

A randomised, double-blind, placebo-controlled, three-way crossover, repeat dose pilot study comparing the effect of inhaled fluticasone furoate/GW642444M combination and fluticasone furoate on the allergen-induced early asthmatic response in subjects with mild asthmaAsthma

EUCTR2009-016581-80-GBGlaxoSmithKline Research & Development Ltd42

进行中（未招募）

不适用

EUCTR2009-016581-80-DEGlaxoSmithKline Research & Development Ltd42

已完成

3 期

A randomised, double-blind, placebo-controlled,multicentre prospective dose-finding Phase II/III studywith atacicept given subcutaneously to subjects havingrecently experienced a flare of systemic lupuserythematosus (SLE)SLEsystemic lupus1000381610010761

NL-OMON39295Merck BV - An affiliate of Merck Serono S.A.34

进行中（未招募）

1 期

BI 655066 / ABBV-066 / risankizumab compared to placebo in patients with active psoriatic arthritisActive Psoriatic ArthritisMedDRA version: 19.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859

EUCTR2015-003625-34-FIBoehringer Ingelheim Finland Ky251