A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder

Table 1 Inclusion criteria

	Inclusion criteria
All participants (n= 72)
Consent	Willing and able to give informed consent for participation in the trial
Demographics
Age	18–55 years
Lifestyle considerations	Agreement to abstain from alcohol and drugs (except regular prescribed medication declared at screening) for 24 h prior to the start of each MRI and EEG session
Medication adherence	Ability and willingness to consume oral medication according to the prescribed dosing regimen
Participants with MDD (n= 48)
Mental health
Diagnosis	MDD according to the DSM-5 criteria
Symptomology	Moderate depression, ≥ 18 on the MADRS
Treatment status	Receiving treatment with an anti-depressant medication
Treatment plan	Plans to remain on the same anti-depressant medication for at least 12 weeks
Peripheral inflammation	Hs-CRP ≥ 3 mg/L or ≤1 mg/L

ISSN: 1745-6215