NCT02828072

Brief Summary

The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

June 30, 2016

Last Update Submit

July 6, 2016

Conditions

AnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Changes in autonomic control

    Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)

    1 month

Study Arms (2)

Sky

EXPERIMENTAL

Sky treatment foe 15 days

Other: SKY therapy

control

SHAM COMPARATOR

standard medical therapy

Drug: usual drug therapy

Interventions

SKY therapyOTHER

slow breathing

Sky
usual drug therapyDRUG
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of anxiety-depression disorder

You may not qualify if:

  • absence of sinus rhythm on ECG
  • absence of any cardiovascular and metabolic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Toschi-Dias E, Tobaldini E, Solbiati M, Costantino G, Sanlorenzo R, Doria S, Irtelli F, Mencacci C, Montano N. Sudarshan Kriya Yoga improves cardiac autonomic control in patients with anxiety-depression disorders. J Affect Disord. 2017 May;214:74-80. doi: 10.1016/j.jad.2017.03.017. Epub 2017 Mar 7.

    PMID: 28285240DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share