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NCT05388110 · ClinicalTrials.gov registry record

SKY Breath Intervention

A clinical trial of Depression and Anxiety Disorders, sponsored by University of California, San Francisco.

Active
Registry status
60
Enrollment target
1
Study location

NCT05388110: Active study of Depression and Anxiety Disorders, sponsored by University of California, San Francisco.

NCT05388110 is a study of Depression and Anxiety Disorders that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 60 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05388110, a study of Depression and Anxiety Disorders, is active but no longer recruiting, sponsored by University of California, San Francisco.

ACTIVE NOT RECRUITING
Registry status
60 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

The differences at 8-week between intervention and controls in depression and anxiety as measured by the Beck Depression Inventory-II. Twenty-one questions, self reporting with scores ranging from 0 to 63. Higher score indicates more severe depression.

Interventions

  • BEHAVIORAL SKY Breath Intervention

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-04-22
Est. Completion 2028-12

What the registry record for NCT05388110 still lists

NCT05388110 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which SKY Breath Intervention is the first listed.

NCT05388110 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05388110 about?

NCT05388110 is a clinical study titled "SKY Breath Intervention". 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 thi...

What is the current status of trial NCT05388110?

This trial is currently active not recruiting. The enrollment target is 60 participants. The study started on 2022-04-22. Estimated completion is 2028-12.

What conditions does trial NCT05388110 study?

This clinical trial studies the following conditions: Depression, Anxiety Disorders.

What interventions are being tested in trial NCT05388110?

The interventions under investigation include: SKY Breath Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT05388110?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05388110 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05388110's enrollment target sits among peer trials

60 428th of 679 higher than 234 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05388110, the US trial registry maintained by the National Library of Medicine. NCT05388110 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.