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

Phase 1

Withdrawn

Interventions: Other: A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Late-life depression population inclusion criteria

Patients in the LLD study arm will be females 60-85 years of age with a general good bill of health
Patients in the LLD study arm will be presenting with mild to moderate MDD. Diagnosis of MDD will be confirmed through a Structured Clinical Interview for DSM-5-TR (SCID) Axis I disorder.
LLD patients will have a Hamilton Depression Rating Scale (17-item version) score between 8-22
LLD patients if being treated with any antidepressant agent, will be at a minimum of 4 weeks at therapeutic dosage of medication.

Healthy control (HC) population inclusion criteria:

HC participants will be females between 60-85 years of age and in good general health
HC participants will have no history of depression.

Exclusion Criteria

A primary diagnosis of any other mental health disorder (including substance dependence, post traumatic stress disorder, obsessive compulsive disorder, bipolar disorder, neurocognitive disorders, personality disorder, etc.)
High risk of suicide as elicited by clinical interview
History of head trauma
History of severe vascular disease or cerebrovascular infarcts
Any history of neurological disease (including Parkinson's disease or seizures)
An ongoing acute episode of systemic inflammatory disease (e.g. rheumatoid arthritis, ulcerative colitis, crohn's disease)
Any contraindications to MRI
Additionally for Healthy Control participants only, a diagnosis of any mental health disorder

Arm && Interventions

Group	Intervention	Description
Late Life Depressed Arm	A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.	Participants in the Late Life Depressed arm will have a confirmed diagnosis of late-life depression.
Healthy Control Arm	A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.	Participants in the Healthy Control Arm will have no history of mental illness.

Primary Outcome Measures

Name	Time	Method
Number of potential participants approached per month.	2 years.	At 2 years the number of potential participants approached per month will be calculated. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Number of potential participants screened.	2 years.	At 2 years the number of potential participants screened will be assessed. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Quality of data available for analysis.	2 years	At 2 years the quality of the data available for analysis will be assessed. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Proportion of screened participants who enroll.	2 years	At 2 years the number of potential participants screened who enroll will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.
Rate of participant retention	2 years	At 2 years the rate of participant retention will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.
Cost per participant	2 years	At 2 years the cost per participant will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.

Secondary Outcome Measures

Name	Time	Method
Central glutathione levels in the brain	week 0	Participants will attend only one assessment. During this assessment central glutathione levels in the brain will be assessed.