Antidepressant trial of a novel P2X7 receptor blocker JNJ-54175446
- Conditions
- Major depressive disorderMental and Behavioural DisordersDepressive episode, Recurrent depressive disorder
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression symptoms measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and week 8 (Visit 4)
- Secondary Outcome Measures
Name Time Method