EUCTR2015-001456-29-DE进行中（未招募）1 期
A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Treatment Resistant Unipolar Major Depressive Disorder (MDD) - Mino-TRD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject information sheets and written informed consent
- •Age 18-75
- •BMI 18- inclusive 40
- •negative pregnancy test
- •safe contraxeptive method (peral index <1)
- •Fulfilment of the criteria for a major depressive disorder according to DSM 5
- •Hamilton Rating Scale for Depression (HAMD-17)-score of at least 16
- •Clinical Global Impression Scale (CGI-S) of at least 4
- •Pharmacotherapy with an market approved antidepressiva in appropriate dose according to SmPC for at least 6 weeks from screening without sufficient response to drug according to MGH ATRQ criteria. A simultaneous treatment with further antidepressiva or for treatment in the indication antidepression used IMP Quetiapin or Aripiprazol in any dosage is possible (f.e. for sleep induction), but must administered for at least 6 weeks before screening, thereof 2 weeks in constant dosage
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Presence of a neurodegenerative disease
- •Presence of a neurological disease, within which the depressive symptoms were associated to a depression
- •Presence of any severe, unstable somatic disease, including chronic inflammatory diseases such as rheumatoid arthritis or chronic inflammatory intestine diseases
- •The depressive symptoms can better be explained by possible comorbid psychiatric disorder, especially a personality disorder
- •Improvement by over 50% in the HAMD-17-score during the past 14 days
- •Pregnancy and breast feeding women
- •Substance or alcohol abuse during the past 6 months or a positive urinary drug Screening (Medication with benzodiazepinen is allowed as well as nicotine consumption)
- •Thyroid dysfunctions (if not substituted euthyroit), severe Malfunction of the liver or kidneys
- •Known autoimmune disease (lifetime prevalence) except euthyroid Hashimoto thyroiditis
- •Clinical relevant laboratory abnormalities
- •Current medication with ant-inflammatory substances (NSAID, Corticosteroids)
- •Current medication with Retinoids (Retinol, Retinoic acid or Retinoid-receptor agonists)
- •Any adverse event occurred in the past which was associated with an earlier intake of tetracyclines, including any hypersensitive reactions to tetracyclines and intolerance of tetracyclines
- •Any medication that is known to interact with Minocycline, in the case of requiring such medication, this will lead to break off the therapy with Minocycline
- •Current medication with barbiturates and other drugs with anticonvulsive effects (e.g. Carbamazepin, Diphenylhydantoin und Primidon)
- •Current medication with beta-lactam antibiotics, i.e. penicillines or cephalosporines
- •Current medication with isotretinoin or medication with isotretinoin during the past 4 weeks
- •Current medication with theophylline
- •Current medication with sulfonylurea antidiabetics and anticoagulants of the cumarine-type
- •Current medication with cyclosporine A
- •Current medication with Methotrexate
- •Being put under methoxyflurane anaesthetics or medication with other substances which could cause kidney damage
- •Lacking willingness to allow storage and transfer of pseudonymized medical data within the clinical Trial
- •Simultaneous administration of other psychtropic substances in addition to standard medication. For the therapy of severe agitation and anxiety as well as major sleeping disorder are only allowed Lorazepam (max. 4 mg/day) or Z-Hypnotics (Zolpidem (max. 10 mg/day), Zopicclone (max. 7.5 mg/day))
- •Participation in a clinical trial according to the AMG during the past 8 weeks
- •Involuntary commitment in an institution by warrant of the court or agency
- •Acute suicidal tendency, suicide plan or attempt in the current disease episode or suicide attempt in the last 5 years
研究者
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