ISRCTN44411633已完成2 期
A randomised, placebo-controlled, double-blind trial of the antidepressant efficacy of a novel CNS-penetrant P2X7 receptor antagonist, JNJ-54175446, in people with major depressive disorder, an incomplete response to monoaminergic antidepressant drugs, and a biomarker profile predictive of active P2X7 signalling
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For a detailed description of inclusion criteria please refer to protocol section 10.1
- •1. Provided written informed consent
- •2. Between the age of 18 to 60 years inclusive
- •3. Meets the DSM-5 diagnostic criteria for MDD (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the M.I.N.I 7.0 (Mini International Neuropsychiatric Interview 7.0)
- •4. Has Hamilton Depression Rating Scale (HDRS) score of > = 17
- •5. BMI between 18 and 36 kg/m2 inclusive
- •6. Currently being treated with one antidepressant monoaminergic drug (e.g. SSRI, SNRI, TCA) at an adequate dose, and for at least 6 weeks and for a maximum of 24 months
- •7. Must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed
- •8. Agree to practice highly effective method of birth control as stated in the protocol
- •9. A woman of childbearing potential must have a negative serum pregnancy test at screening
- •10. Agree not to donate eggs or sperm from start of dosing and for at least 3 months after receiving the last dose of study drug
排除标准
- •For a detailed description of exclusion criteria please refer to protocol section 10.2
- •1. Has a primary DSM-5 diagnosis of posttraumatic stress disorder
- •2. Has failed more than 3 treatments despite an adequate dose and duration, in the last 24 months
- •3. Loss of function allele at one or both of two SNPs on the P2RX7 gene: rs3751143 (1487 A> C) and rs1653624 (1703 T> A)
- •4. Has a current or recent history of clinically significant suicidality
- •5. Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening
- •6. Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)
- •7. Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)
- •8. Has used:
- •8.1. Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening
- •8.2. Within 6 weeks prior to enrolment use of other antidepressant drugs not belonging to the allowed classes of SSRI, SNRI, or TCA.
- •9. Is currently treated with antipsychotic drugs (D2-antagonists; except for low-dose quetiapine), lithium, other mood stabilizers or opiates
- •10. Unable to complete MRI scans
- •11. Has current signs/symptoms of liver or renal insufficiency, diabetes mellitus (type I and II), hypothyroidism or hyperthyroidism without stable treatment, or other significant and uncontrolled medical conditions
- •12. Is a woman who is pregnant or breastfeeding
- •13. Is a man who plans to conceive a child while enrolled in this study or within 3 months after the last dose of IMP
- •14. Has a history of malignancy within 5 years before screening
- •15. Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of IMP, or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study
- •16. Venous blood concentration of C-reactive protein, measured by high sensitivity assay (hs-CRP) less than 1 mg/
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