A Breathing-Based Meditation Intervention for Patients With Treatment Resistant Late Life Depression (NCT03368560) | Clinical Trial Compass
WithdrawnPhase 1
A Breathing-Based Meditation Intervention for Patients With Treatment Resistant Late Life Depression
Stopped: Funding was not received.
0Started 2020-01-01
Plain-language summary
Late-life depression affects 2-8% of seniors and causes high rates of caregiver distress and risk of suicide. To exacerbate the problem, antidepressants, the cornerstone of therapy, are resistant in 55-80% of this population. Hence, this group of patients is labeled as having treatment-resistant late-life depression (TR-LLD).
Non-pharmacological interventions like meditation could offer significant benefits as augmentation strategies to improve response rate of antidepressants in TR-LLD. One such breath-based meditation intervention called Sudarshan Kriya Yoga is of interest based on highly significant preliminary data in adult patients with treatment-resistant depression, its scalability and relatively low cost to learn this lifelong skill.
Thirty patients diagnosed with TR-LLD will learn this intervention over 5 consecutive days by a certified para-professional trainer. This will be followed by 3 weekly 90 min follow-up sessions and then bimonthly sessions for 8 more weeks. SKY consists of a series of breathing techniques, including Sudarshan Kriya (SK), a sequential rhythm-specific breathing exercise. Participants will be asked to practice this technique for 25-30 minutes daily over the next 11 weeks. The investigators will collect clinical as well as feasibility outcome measures. The investigators will also explore if it is feasible to assess the antioxidant Glutathione (GSH) in the brain using a sophisticated magnetic resonance spectroscopy. The investigators suspect that GSH levels are reduced in TR-LLD and they will improve with SKY.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 60-80 years of age
* major depressive disorder, as per the results of an interview by a trained rater using the Structured Clinical Interview for DSM-5 and subsequently confirmed by the psychiatrist
* Mild to moderate depression as confirmed by a score on the HAM-D 17 between 8 and 23
* Have failed at least two trials of antidepressants, given at adequate doses for adequate duration during the current episode
* Able to follow verbal instructions and sit without physical discomfort for 45 minutes
* Willing and able to attend at least 75% of all Sudarshan Kriya Yoga (SKY) sessions
* Willing to dedicate 25-30 minutes/day to SKY practice at home
* Low risk of suicide based on a clinical initial interview and during follow-up interviews at weeks 4, 8 and 12.
Exclusion Criteria:
* Uncontrolled hypertension, seizure disorder, psychosis, substance abuse, or dementia
* Currently participating in other similar studies or currently practicing any type of formal meditation, mindfulness or breathing techniques
* A major surgery within 6 weeks prior to commencement of or scheduled during, the study intervention
* A traumatic brain injury
* Any contraindications to MRI will also be excluded
* Healthy control participants must have no significant mental health issues, or contraindications to MRI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17).
Timeframe: 12 weeks
Trial details
NCT IDNCT03368560
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's