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

Primary Purpose

Female, Late Life Depression

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Female, Late Life Depression

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Late Life Depressed Arm

Healthy Control Arm

Arm Description

Participants in the Late Life Depressed arm will have a confirmed diagnosis of late-life depression.

Participants in the Healthy Control Arm will have no history of mental illness.

Outcomes

Primary Outcome Measures

Number of potential participants approached per month.
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.
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.
Proportion of screened participants who enroll.
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
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
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.
Quality of data available for analysis.
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.

Secondary Outcome Measures

Central glutathione levels in the brain
Participants will attend only one assessment. During this assessment central glutathione levels in the brain will be assessed.

Full Information

First Posted
April 28, 2016
Last Updated
March 2, 2020
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02757833
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
A larger study collecting the same outcomes is currently being conducted by the study team.
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female, Late Life Depression

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Late Life Depressed Arm
Arm Type
Other
Arm Description
Participants in the Late Life Depressed arm will have a confirmed diagnosis of late-life depression.
Arm Title
Healthy Control Arm
Arm Type
Other
Arm Description
Participants in the Healthy Control Arm will have no history of mental illness.
Intervention Type
Other
Intervention Name(s)
A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of potential participants approached per month.
Description
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.
Time Frame
2 years.
Title
Number of potential participants screened.
Description
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.
Time Frame
2 years.
Title
Proportion of screened participants who enroll.
Description
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.
Time Frame
2 years
Title
Rate of participant retention
Description
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.
Time Frame
2 years
Title
Cost per participant
Description
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.
Time Frame
2 years
Title
Quality of data available for analysis.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Central glutathione levels in the brain
Description
Participants will attend only one assessment. During this assessment central glutathione levels in the brain will be assessed.
Time Frame
week 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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