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A Breathing-Based Meditation Intervention for Patients With Treatment Resistant Late Life Depression

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ClinicalTrials.gov Identifier: NCT03368560
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Late Life Depression Other: Sudarshan Kriya Yoga Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This study will recruit 30 patients with treatment-resistant late life depression, and 7 age-matched controls.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Breathing-Based Meditation Intervention for Patients With Treatment-Resistant Late Life Depression (TR-LLD): A Phase II Trial and Feasibility Study
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sudarshan Kriya Yoga
Thirty participants with treatment-resistant late life depression (TR-LLD) will attend 5 instructional days of Sudarshan Kriya Yoga (SKY), followed by 3 weekly follow-ups, and 8 weeks of bimonthly follow-ups. Participants will also practice SKY for 25 minutes per day at home. These participants will attend 4 mental health assessments at weeks 0, 4, 8, and 12. Thirteen of the recruited TR-LLD will attend an MRI at baseline and post-intervention.
Other: Sudarshan Kriya Yoga
Sudarshan Kriya Yoga (SKY): A 12-week training course conducted by certified instructors from the Art of Living Foundation. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario.SKY training involves attending a week-long (5 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them . Nutritional snacks will be provided during the 5 day SKY training course.

No Intervention: Control
The seven recruited age-matched controls will complete a screening appointment and an MRI only for comparison. Demographic information will also be collected from the control participants. These individuals will not undergo the study intervention.



Primary Outcome Measures :
  1. Severity of TR-LLD as measured by the Hamilton Depression Scale (HAM-D17). [ Time Frame: 12 weeks ]
    The primary outcome measure will be the Hamilton Depression Rating Scale (HAM-D 17) score. The HAM-D17 rates symptoms commonly associated with Major Depressive Disorder (MDD). A total score is calculated based on the first 17 questions of the HAM-D with a score range of 0 to 53. A higher score indicates more severe depression, and a lower score indicates fewer and/or less severe symptoms of depression.


Secondary Outcome Measures :
  1. Glutathione levels measured by a 7-Tesla Magnetic Resonance Imaging (7T-MRI) in TR-LLD. [ Time Frame: 12 weeks ]
    Brain glutathione (GSH) levels, a measure of inflammatory stress, will be measured in the prefrontal cortex at baseline and after 12-weeks of SKY intervention via sophisticated magnetic resonance spectroscopy for TR-LLD. Control participants will complete one such measurement.

  2. Caregiver burden in caregivers of TR-LLD as measured by the Zaritz Caregiver Burden scale. [ Time Frame: 12 weeks ]
    The Zaritz Caregiver Burden scale will be administered to caregivers of TR-LLD participants. This scale indicates the burden placed on caregivers by providing care for TR-LLD patients. A total score will be calculated, with scores ranging from 0 to 88. A lower score indicates little to no burden while a higher score indicates severe burden.

  3. Quality of Life of TR-LLD participants using the European Quality of Life (EQ-5D-5L) scale. [ Time Frame: 12 weeks ]
    The European Quality of Life (EQ-5D-5L) scale will be used to assess the quality of life of study participants. This scale has two scores; the descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system consists of 5 questions each with 5 possible answers allowing for 5 possible health states. A score of 1 indicates no problems with the 5 measured dimensions, while a score of 5 would indicate the most severe possible state for each dimension. The descriptive system includes 5 sub-scores ranging from 1 (no issues) to 5 (severe problems), which will be converted to a specific single index value. The EQ VAS consists of only one question ranging from 0 (worst possible state of health) to 100 (best possible state of health).

  4. Anxiety severity of TR-LLD participants measured by the Geriatric Anxiety Inventory (GAI). [ Time Frame: 12 weeks. ]
    The Geriatric Anxiety Inventory (GAI) assesses anxiety in geriatric patients. The questionnaire consists of 20 agree or disagree questions with total scores ranging from 0 (no anxiety) to 20 (severe anxiety).



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368560


Contacts
Contact: Akshya Vasudev, MD 519 667 6693 akshya.vasudev@lhsc.on.ca
Contact: Emily Ionson 519-685-8500 ext 58807 emily.ionson@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute

Responsible Party: Akshya Vasudev, MBBS, MD, MRCPsych, PG Cert Medical Education Associate Professor of Psychiatry and Medicine, Western University Consultant Geriatric Psychiatrist, London Health Sciences Centre, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03368560     History of Changes
Other Study ID Numbers: 110791
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Akshya Vasudev, Lawson Health Research Institute:
Treatment-resistant Late Life Depression
Sudarshan Kriya Yoga
Glutathione

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders