An interventional study of SKY + ASTM + usual care and Usual care in Depression, Quality of Life and Dry Eye, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Supportive care
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Among 532 studies in Depression with a site in Canada — 107 open to participants now, 124 under way, 7 of them phase 3. Depression · Canada.
Among the 532 studies in Depression with a site in Canada, this one is the 257th largest by planned enrollment of the 487 interventional ones that give a count, is one of 33 that started in 2019, is one of 334 with no phase, and was the 234th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →107 of the 532 studies in Depression with a site in Canada are open now. Recruiting first, the newest first:
Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 18+
Eli Lilly and Company · Sites in Canada, United States, Australia and 12 more countries
Ages 18–75
University of Regina · Sites in Canada
Ages 18+
University of Toronto · Sites in Canada
Ages 18+
Lakshmi N Yatham · Sites in Canada
Ages 19–65
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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532 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 45 · Phase 3 55 · Phase 4 37
First in 1997; this study’s year is marked. 33 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 76 across the 487 interventional studies, 262 across the 45 observational. Of the 345 that completed or were terminated, 45 (13%) have results posted.
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59 of 532 have an industry lead sponsor. The 10 most frequent:
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's has 8 studies filed under Depression — fewer than ten, so there is no comparison to draw.
35 of the studies in Depression with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07313657Bruyère Health Research Institute.Improving Care and Mental Well-Being for Adults With Heart Failure | 2026-11-30 |
| NCT05543720University Health Network, TorontoEvaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study | 2026-12 |
| NCT06745349University of ReginaThe Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties | 2026-12 |
Add all 35 to your calendar (.ics) → With an account.
Among the 532 studies in Depression with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision and is associated with depression and have an adverse impact on patient's quality of life. Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression, and anxiety, enhance quality of life in patients diagnosed with DED. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. The investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized to SKY followed by ASTM plus Usual care (UC) or UC alone to assess changes in health-related quality of life (HRQOL). HRQOL is a vital construct focusing on impact of health on quality of life. Along with HRQOL the investigators will measure changes in extent of depression and anxiety. Additionally, majority of current ophthalmic literature describes changes in clinical variables whilst lacking information on HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and routinely measured clinical data. Through this study the investigators shall attempt to correlate HRQOL with clinical data.
Background: Prevalence of dry eye disease (DED) ranges from 3.5% to 33.7% and increase with age. Further, DED is associated with decreased productivity, absenteeism from work, depression, and has an adverse impact on patient's quality of life. Odds of a DED patient suffering from depression is 2.9 and anxiety is 2.8. Yoga - a practice to help improve health and well-being - has also been the subject of clinical studies globally. Two central aspects of yoga practice are physical postures and breathing exercises. These breathing exercises aim to focus the mind, facilitate relaxation and enhance wellness.
Evidence further suggests beneficial effects of a standardized collection of breathing techniques called Sudarshan Kriya Yoga (SKY) on individuals suffering from depression. SKY includes three-stage breathing with Victory breath (slow deep breathing that consists of 4 to 6 breaths per minute), Bellow's breath (forceful rapid deep breathing that consists of 20 to 30 breaths per minute), and a rhythmic breath technique. SKY followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation. ASTM utilizes a specific sound value mantra to draw attention inward and permit the mind to experience a restful but alert state of consciousness. It helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. ASTM may help with depression, anxiety, stress, and may enhance quality of life. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. Key goal of proposed research is to evaluate HRQOL, depression, anxiety of patients with DED in SKY followed by ASTM and usual care (UC) versus UC alone from baseline to 24 weeks.
Primary Hypothesis: The investigators hypothesize that in patients with dry eye disease in SKY + ASTM + UC may lead to significant improvement in HRQoL compared to UC alone from baseline to 24 weeks.
Secondary Hypotheses: The investigators hypothesize that in patients with DED 1) HRQoL is associated with regularly measured clinical variables 2) SKY + ASTM + UC leads to significant improvement in depression and anxiety symptoms at 24 weeks compared to UC alone.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) plus usual care
Other: SKY + ASTM + usual care
Treatment as usual
Other: Usual care
Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation.
Treatment as usual
Change in Health Related Quality of Life (HRQoL)
Health Related Quality of LIfe (HRQoL) is an essential measure of quality of life related to health. HRQoL will be measured using time trade-off (TTO) questionnaire. HRQoL varies between 0 and 1 where the score of 1 represents perfect health and 0 represents death.
Time frame: Up to 24 weeks
Visual Function Score
Visual related quality of life measured using National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). The most widely used instrument in vision-related functioning is the NEI VFQ-25. It was designed specifically for a clinical setting and consists of 12 domains: general health, general vision, visual pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, colour vision and peripheral vision. The shorter 25-item version questionnaire is widely used in different groups of patients and shown to be internally consistent, reproducible and responsive in glaucoma patients. The NEI VFQ-25 scores have a closer relationship to clinical outcomes, in comparison to generic instruments. The scores range from 0 to 100 where higher score represents better vision related quality of life.
Time frame: Up to 24 weeks
Depression
Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure depression. It is one of the most common validated tools used to measure depression in research to identify depressive symptoms. Additionally, it is a brief standardized valid tool for assessing depressive symptoms. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
Time frame: Up to 24 weeks
State and Trait Anxiety
State-Trait Anxiety Inventory (STAI)
Time frame: Up to 24 weeks
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 24 weeks
Community Integration
The community integration questionnaire (CIQ) was used to provide a quantitative indicator for the level of social support and ability to perform appropriate roles at home and within the community. The CIQ contains 15-items and uses behavioural items of integration to achieve better reliability. The total CIQ score ranges from 0 to 29, with a higher score representing a higher level of social support and complete community integration.
Time frame: Up to 24 weeks
Canadian Dry Eye Assessment
Canadian Dry Eye Assessment
Time frame: Up to 24 weeks
Dry Eye Assessment
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Time frame: Up to 24 weeks
Plan to share: No — De-identified IPD collected in this study will not be available to other researchers (e.g. outside the primary research group). Because the primary research group has the necessary expertise to conduct analysis and do not need any outside help.
Start is estimated for Jul 2019; primary completion for Sep 2020, 14 months later.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 14 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →