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 range60 Years – 80 Years

SexALL

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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.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31