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

L

Lawson Health Research Institute

Status and phase

Withdrawn
Phase 1

Conditions

Female, Late Life Depression

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02757833
10012689

Details and patient eligibility

About

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).

Full 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.

Sex

Female

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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