Clinical trial NCT02757833: Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study
Official title: Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Female, Late Life Depression
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of potential participants approached per month.
timeFrame: 2 years.
measure: Number of potential participants screened.
timeFrame: 2 years.
measure: Proportion of screened participants who enroll.
timeFrame: 2 years
measure: Rate of participant retention
timeFrame: 2 years
measure: Cost per participant
timeFrame: 2 years
measure: Quality of data available for analysis.
timeFrame: 2 years
Secondary outcomes:
measure: Central glutathione levels in the brain
timeFrame: week 0
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: