NCT04977674

Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine

Investigating Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The overarching aim of this research is to determine the acute effects of ketamine on brain glutamate, functional connectivity and cerebral blood flow in treatment-resistant depression, explore whether the effects are attenuated by the opioid receptor antagonist naltrexone and relate these findings to antidepressant response.

Detailed description

The study is a randomised, double-blind, crossover design with two treatment conditions: oral placebo or oral naltrexone preceding ketamine infusion during neuroimaging in subjects with treatment-resistant depression. Each subject will participate in two imaging sessions on two separate days. Each subject will receive a dose of ketamine (IV infusion, 0.5 mg/kg over 40 minutes) during each scan. Subjects will receive either oral placebo or naltrexone 50 mg, 45 minutes before the initiation of each of the ketamine infusions.

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Naltrexone	Pre-treatment with naltrexone 45 min before the ketamine infusion.
DRUG	Placebo	Pre-treatment with placebo 45 min before the ketamine infusion.
DRUG	Ketamine	Participants receive intravenous ketamine infusion (0.5 mg/kg over 40 min) at both study visits.

Timeline

• Start date: 2021-09-27
• Primary completion: 2023-02-13
• Completion: 2023-02-20
• First posted: 2021-07-27
• Last updated: 2023-03-02

Locations

1 site across 1 country: United Kingdom