ow-dose naltrexone as an adjunctive treatment in major depressive disorder.
- Conditions
- Major depressive disorder (MDD)Mental Health - Depression
- Registration Number
- ACTRN12622000881730
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion criteria for participants with depression:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 to 55 years.
- Diagnosis of MDD as per the Diagnostic and Statistical Manual 5 criteria for MDD
- Experiencing significant depressive symptoms, as indicated by a score greater than or equal to 18 on the MADRS
- Receiving treatment with an antidepressant agent (not greater than Stage II antidepressant resistance as defined by the Thase and Rush treatment-resistant depression staging method)
- Clinically stable for at least four weeks
- hsCRP levels either greater than or equal to 3 mg/L, or less than or equal to 1 mg/L
- Ability to take oral medication and be willing to adhere to the dosing regimen
- Agreement to adhere to Lifestyle Considerations throughout study duration (participants will be asked to abstain from alcohol and drugs for 24 hours before the start of each MRI and EEG session, and have a plan with their doctor to stay on the same antidepressant for at least 12 weeks).
Inclusion criteria for healthy controls:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged 18 to 55 years
-hsCRP levels less than or equal to 1 mg/L
- Agreement to adhere to Lifestyle Considerations throughout study duration (healthy participants will be asked to abstain from alcohol and drugs for 24 hours before the start of each MRI and EEG session)
Exclusion criteria for participants with depression:
- Current use of prescription opioid analgesics, psychostimulants, dopamine agonists
- Current use of any opioid-based drugs recreationally
- Any current or past bipolar or psychiatric disorder or psychotic features (other psychiatric conditions such as anxiety will be allowed for individuals with MDD, provided they are not the primary source of the participant’s depressive symptomatology)
- Acute risk of suicide
- Any known neurological disorders or neurodegenerative condition
- Acute infectious pathology, or chronic or acute inflammatory diseases that, in the judgement of the investigators, interferes with study measures or procedures
- Any clinically significant medical conditions, e.g., renal, hepatic, or cardiovascular conditions, uncontrolled thyroid dysfunction, metabolic disorders, cancer, seizure disorders
- Uncontrolled autoimmune diseases or severe chronic pain
- Or any other condition that, in the judgement of the investigators, interferes with study measures or procedures
- Long-term, frequent, anti-inflammatory or immunosuppressive therapy
- Contraindications to MRI or blood tests, including those who refuse to be informed of an incidental finding
- Women who are pregnant or breastfeeding, or women of child-bearing age who are not on a medically acceptable form of contraception
- Substance use disorders within the previous 12 months
- Any allergy or intolerance to naltrexone
Exclusion criteria for healthy controls:
- Current use of any medication other than contraception
- Current use of any opioid-based drugs recreationally
- Any current or past psychiatric conditions
- Any known neurological disorders or neurodegenerative condition
- Acute infectious pathology, or chronic or acute inflammatory diseases
- Any clinically significant medical conditions, e.g., renal, hepatic, or cardiovascular conditions, uncontrolled thyroid dysfunction, metabolic disorders, history of cancer, seizure disorders
- Autoimmune diseases or chronic pain
- Long-term anti-inflammatory or immunosuppressive therapy
- Contra-indications to MRI or blood tests, including those who refuse to be informed of an incidental finding.
- Women who are on hormone suppressants.
- Women who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression assessed by Montgomery- Åsberg depression rating scale (MADRS) score[ MADRS will be assessed at weeks 0 (baseline), 2, 4, 8, and 12 after starting treatment. The primary endpoint being the fifth assessment in week 12.]
- Secondary Outcome Measures
Name Time Method