Microdose Antagonist Combination for Depression (MAC-D) Trial: combination of low dose naltrexone and flumazenil for treatment of major depressive disorder

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12621000310864
• Lead Sponsor: Trexapharm Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-19
• Study Completion: 2022-11-23
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Major Depressive Disorder, with any current symptoms according to DSM criteria. There will be no inclusion criteria based on symptom range or severity.

Treatment resistance defined as 3 (three) or more failed trials of antidepressant treatments of adequate dose and duration, which can include neurostimulation and/or completed structured psychotherapy.

Exclusion Criteria

Patients will be excluded if they suffer hepatitis or hepatic failure, severe immunosuppression, multiple sclerosis, epilepsy or have a history of seizures, organ transplantation, are pregnant or are breastfeeding, take >5mg daily dose equivalent of Diazepam, are under 18 years of age or are unable or unwilling to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified