NCT06091527

Brief Summary

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial is to evaluate antidepressant efficacy of yoga monotherapy of 12-weeks duration in 180 adults meeting diagnostic criteria for mild-to-moderate major depression at the Zuckerberg San Francisco General Hospital. Researchers will compare the yoga interventions to an education control intervention on holistic healthcare.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress96%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

October 13, 2023

Last Update Submit

November 4, 2025

Conditions

Depression MildDepression Moderate

Keywords

yogaayurvedadepression

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Depression Inventory-II score

    The Beck Depression Inventory-II is one of the most commonly used instruments in psychiatric research; it has been translated and validated in many different languages, appearing in hundreds of studies worldwide. The Beck Depression Inventory-II is a 21-item validated instrument for the self-report of depressive symptoms; it can typically be completed in 5 minutes. Each item on the Beck Depression Inventory-II can be scored from 0 to 3, with the total score derived by summing the individual item scores. A total score of 14-19 suggests mild depression, 20-28 suggests moderate depression, and 29-63 suggests severe depression.

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks

Secondary Outcomes (6)

  • Change in Perceived Stress Scale score

    Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks

  • Change in methylation of the GrimAge epigenetic clock

    Baseline and 12 weeks

  • Change in transcription of the nuclear factor kappa-B (NF-κB) pathway

    Baseline and 12 weeks

  • Change in plasma interleukin-6 (IL-6) level

    Baseline and 12 weeks

  • Change in telomere length of leukocytes

    Baseline and 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Yoga practice

EXPERIMENTAL

Yoga practice groups

Behavioral: Yoga practice

Education

ACTIVE COMPARATOR

Education module group

Behavioral: Education

Interventions

Yoga practiceBEHAVIORAL

90-minute group yoga classes twice weekly for 12 weeks.

Yoga practice
EducationBEHAVIORAL

90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

Education

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Able to give voluntary, informed consent
  • English-speaking
  • Diagnosis of clinical depression

You may not qualify if:

  • Current use of antidepressant medication
  • Current engagement in psychotherapy
  • Current pregnancy
  • Significant medical issues interfering with yoga practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Related Publications (9)

  • Prathikanti S, Rivera R, Cochran A, Tungol JG, Fayazmanesh N, Weinmann E. Treating major depression with yoga: A prospective, randomized, controlled pilot trial. PLoS One. 2017 Mar 16;12(3):e0173869. doi: 10.1371/journal.pone.0173869. eCollection 2017.

    PMID: 28301561BACKGROUND

  • Wu Y, Yan D, Yang J. Effectiveness of yoga for major depressive disorder: A systematic review and meta-analysis. Front Psychiatry. 2023 Mar 23;14:1138205. doi: 10.3389/fpsyt.2023.1138205. eCollection 2023.

    PMID: 37032928BACKGROUND

  • Naveen GH, Varambally S, Thirthalli J, Rao M, Christopher R, Gangadhar BN. Serum cortisol and BDNF in patients with major depression-effect of yoga. Int Rev Psychiatry. 2016 Jun;28(3):273-8. doi: 10.1080/09540261.2016.1175419. Epub 2016 May 13.

    PMID: 27174729BACKGROUND

  • Deng W, Cheung ST, Tsao SW, Wang XM, Tiwari AF. Telomerase activity and its association with psychological stress, mental disorders, lifestyle factors and interventions: A systematic review. Psychoneuroendocrinology. 2016 Feb;64:150-63. doi: 10.1016/j.psyneuen.2015.11.017. Epub 2015 Nov 25.

    PMID: 26677763BACKGROUND

  • Nugent NR, Brick L, Armey MF, Tyrka AR, Ridout KK, Uebelacker LA. Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression. Behav Med. 2021 Jan-Mar;47(1):21-30. doi: 10.1080/08964289.2019.1604489. Epub 2019 May 29.

    PMID: 31141465BACKGROUND

  • Pisanu C, Tsermpini EE, Skokou M, Kordou Z, Gourzis P, Assimakopoulos K, Congiu D, Meloni A, Balasopoulos D, Patrinos GP, Squassina A. Leukocyte telomere length is reduced in patients with major depressive disorder. Drug Dev Res. 2020 May;81(3):268-273. doi: 10.1002/ddr.21612. Epub 2019 Nov 1.

    PMID: 31675136BACKGROUND

  • Protsenko E, Yang R, Nier B, Reus V, Hammamieh R, Rampersaud R, Wu GWY, Hough CM, Epel E, Prather AA, Jett M, Gautam A, Mellon SH, Wolkowitz OM. "GrimAge," an epigenetic predictor of mortality, is accelerated in major depressive disorder. Transl Psychiatry. 2021 Apr 6;11(1):193. doi: 10.1038/s41398-021-01302-0.

    PMID: 33820909BACKGROUND

  • Tolahunase MR, Sagar R, Faiq M, Dada R. Yoga- and meditation-based lifestyle intervention increases neuroplasticity and reduces severity of major depressive disorder: A randomized controlled trial. Restor Neurol Neurosci. 2018;36(3):423-442. doi: 10.3233/RNN-170810.

    PMID: 29614706BACKGROUND

  • Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.

    PMID: 32849047BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sudha Prathikanti, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudha Prathikanti, MD

CONTACT

415-516-3867sudha.prathikanti@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

October 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)