Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT04116606
Eligibility Criteria:
The key eligibility criteria are listed below, to obtain the full list please contact the trial team.
Inclusion Criteria:
1. Provided written informed consent
2. Between the age of 18 to 60 years inclusive
3. Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0.
4. Has PHQ-9 score of ≥10.
5. BMI between 18.0 and 36.0 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.
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.
Exclusion Criteria:
1. Has a primary DSM-5 diagnosis of posttraumatic stress disorder.
2. Has failed to respond to more than 3 antidepressant treatments despite an adequate dose and duration, in the last 24 months.
3. Presence of two copies of the loss-of-function C allele at rs3751143, and/or has one copy of the loss-of-function A allele at rs1653624 in the P2RX7 gene.
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. 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.
17. Has had major surgery, (i.e. requiring general anaesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04116606
Study Brief:
Protocol Section:
NCT04116606