Female, Late Life DepressionPhase 1NCT02757833
Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study
A Phase 1 study testing A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. in people with Female, Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, Late Life Depression
- What is being tested?
- A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2019to 15 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Late Life Depressed Arm | Other | Participants in the Late Life Depressed arm will have a confirmed diagnosis of late-life depression. Receives: Other: A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. |
| Healthy Control Arm | Other | Participants in the Healthy Control Arm will have no history of mental illness. Receives: Other: A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years.
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.
Measured: 2 years.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (1)
Central glutathione levels in the brain
Participants will attend only one assessment. During this assessment central glutathione levels in the brain will be assessed.
Measured: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start15 Feb 2019
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Why it stopped: A larger study collecting the same outcomes is currently being conducted by the study team.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female, Late Life DepressionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757833
- Sponsor's protocol ID
- 10012689
- Status last verified
- Feb 2020
- First submitted
- 28 Apr 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT02757833
- Acronym / sponsor ID
- 10012689
- Conditions
- Female, Late Life Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A larger study collecting the same outcomes is currently being conducted by the study team.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late Life Depressed Arm | Other | Other: 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 | Other | Other: 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy Control Arm, Late Life Depressed Arm |
Primary outcome
Number of potential participants approached per month.
Time frame: 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.
Time frame: 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.
Proportion of screened participants who enroll.
Time frame: 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
Time frame: 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
Time frame: 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.
Quality of data available for analysis.
Time frame: 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.
1 secondary outcome
Central glutathione levels in the brain
Time frame: week 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. in people with Female, Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of potential participants approached per month. (time frame: 2 years.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.