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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Major depressive disorder (MDD)
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The purpose of this study is to test the drug tildacerfont, which is being developed for the treatment of Major Depressive Disorder (MDD). MDD is a highly debilitating mental disorder, ranked as one of the leading causes of disability worldwide by the World Health Organisation. Many people do not gain sufficient benefit or suffer side effects from the current approved medications. The current antidepressant pharmaceutical therapies, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants, have several limitations. There is an unmet need for novel treatments that offer better clinical outcomes by adequately addressing the underlying biology of depression. Increasing attention is drawn to the field of precision psychiatry, which aspires to provide personalised treatments for patients, after accounting for their biological variabilities. The aim is to allocate patients to treatments they are most likely to benefit from, by accurately characterising their genetics, neuronal circuits and other physiological parameters. This study will evaluate the use of tildacerfont for depression in people with a positive CRHR1CDx result, which the Sponsor believes reflects a predisposition for altered stress regulation.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. A CRHR1CDx-negative result2. Currently ongoing psychiatric and neurological concomitant condition3. Significant risk of suicide4. Unable to complete or tolerate wash-out from current antidepressant medication (if applicable). Participants who are able to wash out but require a longer wash-out period that is not considered appropriate will be excluded5. Wash-out of existing antidepressant medication (if applicable) is considered unsuitable for the participant (e.g., participant is receiving benefit from their existing antidepressant treatment in the opinion of the Investigator, or the risks of discontinuation outweigh the benefit of participating in the trial)6. Known or suspected lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative CNS disorder, epilepsy or any other disease/procedure/accident/intervention7. Known or suspected cardiovascular/cerebrovascular disease8. Untreated hypertension and a systolic blood pressure >160 mmHg (at rest) and/or diastolic blood pressure >100 mmHg (at rest) at screening9. Clinically relevant abnormal ECG findings at screening, including a QTcF ≥470 msec in females or ≥450 msec in males10. Clinically relevant abnormal laboratory results, vital signs or physical findings at screening11. A history of, or symptoms and signs suggestive of, impaired hepatic function or cirrhosis, including an ALT or AST value >2 × the ULN, and/or total bilirubin >1.5 × the ULN, and/or total bile acids >5 × the ULN, and/or a ratio of ALT: alkaline phosphatase (ALP) normalised to ULN for each ([ALT/ULNALT]/ [ALP/ULNALP] >5, at screening. 12. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus 1 and 2 (anti-HIV 1/2) at screening13. Cushing’s Syndrome14. Addison’s Disease15. Renal insufficiency16. Uncontrolled diabetes (glycated haemoglobin [HbA1c] >8.0% at screening) or diabetes treatment ongoing for less than 3 months prior to screening17. Known but untreated conditions causing hyperthyroidism or hypothyroidism, with the following 18. Hypopituitarism or bilateral adrenalectomy19. Participants with any significant disease or disorder 20. A history of moderate to severe alcohol use and/or substance use disorder21. A positive result on the urine drug screen for substances of abuse (Table 3) at screening22. Intake of benzodiazepines during the trial is prohibited (see Appendix 3 for exceptions and restrictions)23. A history of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental CNS treatment during the current episode or within 6 months prior to screening24. Donation or loss of whole blood ≥500 mL within 2 weeks prior to first dosing. Blood donation during the 8 weeks of IMP intake is prohibited25. Participants who have received an IMP or used an invasive investigational medical device in a clinical trial, within 6 months prior to screening. Use of any investigational drugs (with the exception of tildacerfont) is prohibited during the trial26. Participation in 2 or more clinical interventional trials within 1 year prior to screening27. Current enrolment in a clinical interventional trial28. Female participants of childbearing potential who are pregnant, breastfeeding or planning to conceive during the course of the trial and follow-up29. Male participant who will not abstain from sperm donation from screening until at least 90 days after final dosing30. Female participant who will not abstain from egg donation from screening until at least 30 days after final dosing31. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the ADME of the trial medication32. Personal or family history of sudden death/long QT syndrome33. Any history of significant bleeding/haemorrhagic tendencies34. History of severe adverse reactions or allergies, or history of an anaphylactic reaction to prescription or non-prescription medication or food (non-active hay-fever is acceptable)35. Participants who routinely work overnight shifts36. Employees of the Investigator, trial centre, Sponsor, clinical research organisation or trial consultants, when employees are directly involved in this trial or other studies under the direction of this Investigator or trial centre, and their family members37. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.38. Any antidepressant treatment39. OTC medications and herbal extracts intended for the treatment of mood disorders40. Use of hormonal agents prohibited 41. Cough/cold medications containing dextromethorphan42. Current treatment with opioids/barbiturates43. Strong inhibitors of CYP3A4 44. Intake of any sleep/anti-anxiety medication is prohibited within 24 hours before on-site visit45. Systemic treatment with corticosteroids or other drugs with a potential effect on the HPA axis
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by MAC Clinical Research and funded by HMNC Holding GmbH.
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