NCT02757833

Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: Female
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Female participants with an episode of late-life depression (LLD) and age-matched control participants with no history of mental disorder will attend a one hour Magnetic Resonance Imaging (MRI). A 3 Tesla MRI scanner will be used to measure levels of glutathione (GSH) in the brain via magnetic resonance spectroscopy (1H MRS).

Detailed description

This is a pilot/feasibility, single-centre, open-label, cross-sectional study. Research participants will be women aged 60 to 85. This study seeks to recruit 26 female participants; 13 participants with a confirmed diagnosis of late-life depression and 13 control participants with no history of mental illness. This pilot study will be used to determine if a larger Randomized Controlled Trial is feasible. The role of antioxidant capacity in Late Life Depression (LLD) has thus far been inadequately assessed, providing the investigators with a timely opportunity to spearhead such an investigation. The results of this pilot study, and subsequent large-scale studies, will allow the investigators to identify novel targets for therapeutic intervention in LLD.

Conditions

• Female, Late Life Depression

Interventions

Type	Name	Description
OTHER	A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.	Using the MEGA-PRESS pulse sequence, high resolution T1-weighted sagittal anatomic images covering the brain using an inversion-prepared MP-RAGE pulse sequence to produce high grey/white matter contrast will be acquired. These will be used to localize the spectroscopy voxel in the vmPFC. Magnetic field homogeneity will be optimized in the voxel using an automated map shimming procedure. MEGA-PRESS spectra will be acquired to detect the glutathione cysteinyl ß-CH2 peak at 2.95 ppm with the editing pulse set at the j-coupled a-CH resonance at 4.95 ppm. A reference unsuppressed water spectrum will be acquired for absolute quantification. Metabolite spectra will be fitted in the time domain using a Levenberg-Marquardt least squares minimization routine. The contribution of each metabolite to the in-vivo spectrum can be scaled to the water signal intensity from within the voxel of interest to obtain an absolute measurement of metabolite concentration.

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-02-15
• Completion: 2019-02-15
• First posted: 2016-05-02
• Last updated: 2020-03-04

Locations

1 site across 1 country: Canada