Antidepressant trial of a novel P2X7 receptor blocker JNJ-54175446.
- Conditions
- Major depressive disorder with an incomplete response to monoaminergic antidepressants and with biomarker profile indicative of inflammationMedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-001884-21-GB
- Lead Sponsor
- Cambridgeshire and Peterborough NHS Foundation Trust and University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 142
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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:
-Monoamine oxidase inhibitors (MAOIs) within 12 weeks before screening
-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 breast feeding.
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/L.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method