2024-520076-10-01招募中2 期
Targeting inflammation in depression using Minocycline: a patient stratification approach using peripheral inflammatory biomarkers, PET and MRI
Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in the levels of peripheral inflammatory biomarkers in depressed patients before and after 8 weeks of treatment with Minocycline.
研究概览
简要总结
To evaluate an improvement in the peripheral inflammatory status in depressed patients after 8 weeks of treatment with Minocycline in addition to their current pharmacological treatment
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Being male or female depressed patients (aged 18-60);
- •Having a current DSM-V diagnosis of nonpsychotic major depressive disorder confirmed by SCID;
- •Being non-responder to a current SSRI for at least 8 weeks, and historically to one other SSRI;
- •Being in stable antidepressant therapy for at least 8 weeks;
- •Being tolerant to the current SSRI;
- •Accepting Minocycline treatment;
- •Having CPR level> 2 mg/L;
- •Having signed and dated an informed consent to participate in the study;
- •Having no contraindications to receive treatment with Minocycline;
- •Having no contraindications to undergo the 11C-PK PET scan.
排除标准
- •Having active suicidal ideation;
- •Having a primary diagnosis of bipolar disorder, obsessive-compulsive disorder, eating disorder, PTSD;
- •Having a history of substance/alcohol abuse;
- •Having received tetracycline therapy within the previous 2 months;
- •Having a history of sensitivity to this class of drugs;
- •Having acute infections or an autoimmune or inflammatory disorder;
- •Having CRP>20 mg/L, as indicates acute infection or other major pathology;
- •Being sensitive to Minocycline;
- •Having a history of severe allergy or hypersensitivity to drugs;
- •Being hypersensitive to the active substance, to other tetracyclines or to any of the excipients;
- •Having severe renal failure;
- •Having hepatic dysfunction;
- •Being pregnant and in lactation;
- •(for MRI) Having pacemakers, electromechanical devices, ferromagnetic vascular clips, cochlear implants, stapedial prostheses, ferromagnetic foreign bodies, sickle cell anemia;
- •Having undergone imaging or treatment procedures using radiopharmaceuticals 7 days prior to the imaging session of this study (applicable only to patients who will undergo PET scan);
- •Being unable to complete the 11C PK PET session, according to the clinician (applicable only to patients who will undergo PET scan);
- •Being in current or previous (last two months) treatment with neuroactive drugs (benzodiazepines, barbiturates, picrotoxin and muscimol) (applicable only to patients who will undergo PET scan);
- •Being women of childbearing potential who are not surgically sterile and who do not guarantee to abstain from sexual activity for the 24 hours following the administration of 11C PK PET (applicable only to patients who will undergo PET scan).
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Changes in the levels of peripheral inflammatory biomarkers in depressed patients before and after 8 weeks of treatment with Minocycline.
Changes in the levels of peripheral inflammatory biomarkers in depressed patients before and after 8 weeks of treatment with Minocycline.
次要结局
- Changes in depressive symptoms in depressed patients before and after 8 weeks of treatment with Minocycline
- Structural and functional brain changes before and after 8 weeks of treatment with Minocycline
- Changes in the inflammatory status in the brain, in terms of microglia activation, before and after 8 weeks of treatment with Minocycline
- Associations among changes in MRI, in microglia activation, peripheral inflammation and any improvement in depressive symptoms
研究者
Annamaria Cattaneo
Scientific
Provincia Lombardo Veneta Dell’Ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli
研究点 (2)
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