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NCT05388110 · ClinicalTrials.gov record · last posted 2026-08-11

SKY Breath Intervention

StatusTerminated
PhaseNot specified
Started2022-04-22
View on ClinicalTrials.gov ↗
Why the trial stopped
The study was terminated due to limited resources and the loss of key study personnel, which made completion of the planned enrollment infeasible. The decision was not based on safety or efficacy concerns.
from the ClinicalTrials.gov record
Depression is highly debilitating and prevalent among adolescents. Adolescent-onset depression is associated with long, severe, and recurrent episodes that are often not responsive to treatment. There is a dire need to develop novel treatments that are efficient, cost-effective, and tolerant for this population. Sudarshan Kriya Yoga (SKY) is a breath-based meditative practice that entails a sequence of specific breathing techniques to help practitioners achieve a state of calm alertness. It has offered benefits as a therapeutic option for mild-to-moderate depression and anxiety disorders and as an adjunctive treatment in patients with major depressive disorder, but the neurological mechanism of SKY breath intervention is still not fully understood. The goal of this study is to determine the efficacy of SKY breath intervention in treating depressed adolescents and to understand its mechanisms. In this study, thirty depressed adolescents and thirty healthy controls will be recruited to evaluate the efficacy of the 8-week SKY intervention. Assessment for depression and anxiety, salivary cortisol, resting heart rate, blood pressure, and neuroimaging will be collected at the baseline, 4 weeks into SKY intervention (questionnaires only), and post-intervention. This will be the first study to evaluate the potential benefits of of SKY breath intervention as a treatment option for depressed adolescents.

Protocol amendment history 5 changes detected by DataLookout

2026-08-12
critical
Trial terminated
2026-08-12
critical
Trial terminated: The study was terminated due to limited resources and the loss of key study personnel, which made completion of the pla...
2026-08-12
critical
Enrollment reduced: 60 → 14 participants
2026-08-12
minor
Primary completion moved earlier: 2028-04 → 2023-12-31
2026-08-12
minor
Completion moved earlier: 2028-12 → 2023-12-31
Trial Details
NCT Number NCT05388110
Lead Sponsor University of California, San Francisco
Conditions Depression, Anxiety Disorders
Enrollment 14 participants
Start Date 2022-04-22
Primary Completion 2023-12-31 (estimated)
Study Completion 2023-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11