Depression MildNCT06091527
Treating Major Depression With Yoga Mono-therapy
A study testing Yoga practice and Education in people with Depression Mild and Depression Moderate, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- Yoga practice and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Able to give voluntary, informed consent
- English-speaking
- Diagnosis of clinical depression
Who cannot join
- Current use of antidepressant medication
- Current engagement in psychotherapy
- Current pregnancy
- Significant medical issues interfering with yoga practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Sudha Prathikanti, MD, 415-516-3867, sudha.prathikanti@gmail.com
Sudha Prathikanti, MD
About this study
Official title: Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
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.
Read the detailed description
Consenting participants will be randomized equally to one of three in-person group interventions for 12 weeks: Standard yoga practice, Ayurvedic yoga practice, or educational attention-control modules. The primary outcome is depression severity, measured by Beck Depression Inventory-II (BDI) scores. Secondary outcomes include perceived stress, measured by Perceived Stress Scale (PSS) scores, and several biomarker assays associated with depression: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, interleukin-6 (IL-6) and brain-derived neurotropic factor (BDNF). Blinded assessors will conduct all outcome analyses at 12 weeks. The primary analysis will test whether the yoga groups combined achieve statistically greater change in BDI scores compared to the control group. Secondary analyses will test whether the yoga groups combined, compared to the control group, demonstrate statistically greater change in PSS scores and the aforementioned biomarker assays. In sub-analyses, investigators will assess whether Ayurvedic yoga participants, compared to Standard yoga participants, demonstrate statistically significant improvements in BDI scores, PSS scores, and depression biomarker assays over the 12-week intervention period.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- Yoga practice, Education
- Keywords
- yoga, ayurveda, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga practiceBehavioural
90-minute group yoga classes twice weekly for 12 weeks.
EducationBehavioural
90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.
| Study group | Role | What they receive |
|---|---|---|
| Yoga practice | Experimental | Yoga practice groups Receives: Behavioral: Yoga practice |
| Education | Active comparator | Education module group Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Secondary outcomes (6)
Change in Perceived Stress Scale score
The Perceived Stress Scale is a commonly used instrument in psychiatric research; it has been translated and in many different languages, appearing in hundreds of studies worldwide. The Perceived Stress Scale is a 10-item validated questionnaire used to assess stress levels in individuals. It can typically be completed in 5 minutes and evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month. Each item on the Perceived Stress Scale can be scored 0 to 4, with the total score derived by summing the individual item scores. Higher scores indicate higher levels of perceived stress and there are no score cut-offs published by the developer.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Change in methylation of the GrimAge epigenetic clock
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Measured: Baseline and 12 weeks
Change in transcription of the nuclear factor kappa-B (NF-κB) pathway
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Measured: Baseline and 12 weeks
Change in plasma interleukin-6 (IL-6) level
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Measured: Baseline and 12 weeks
Change in telomere length of leukocytes
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Measured: Baseline and 12 weeks
Change in plasma brain-derived neurotropic factor (BDNF) level
Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start25 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudha Prathikanti, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091527
- Sponsor's protocol ID
- 23-38755
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28301561Wu 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.
PubMed 37032928Naveen 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.
PubMed 27174729Deng 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.
PubMed 26677763Nugent 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.
PubMed 31141465Pisanu 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.
PubMed 31675136Protsenko 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.
PubMed 33820909Tolahunase 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.
PubMed 29614706Venditti 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.
PubMed 32849047
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06091527
- Acronym / sponsor ID
- 23-38755
- Conditions
- Depression Mild, Depression Moderate
- Keywords
- yoga, ayurveda, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consenting participants will be randomized equally to one of three in-person group interventions for 12 weeks: Standard yoga practice, Ayurvedic yoga practice, or educational attention-control modules. The primary outcome is depression severity, measured by Beck Depression Inventory-II (BDI) scores. Secondary outcomes include perceived stress, measured by Perceived Stress Scale (PSS) scores, and several biomarker assays associated with depression: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, interleukin-6 (IL-6) and brain-derived neurotropic factor (BDNF). Blinded assessors will conduct all outcome analyses at 12 weeks. The primary analysis will test whether the yoga groups combined achieve statistically greater change in BDI scores compared to the control group. Secondary analyses will test whether the yoga groups combined, compared to the control group, demonstrate statistically greater change in PSS scores and the aforementioned biomarker assays. In sub-analyses, investigators will assess whether Ayurvedic yoga participants, compared to Standard yoga participants, demonstrate statistically significant improvements in BDI scores, PSS scores, and depression biomarker assays over the 12-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga practice | Experimental | Behavioral: Yoga practiceYoga practice groups |
| Education | Active comparator | Behavioral: EducationEducation module group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Able to give voluntary, informed consent
- English-speaking
- Diagnosis of clinical depression
Key exclusion criteria (4 listed)
- Current use of antidepressant medication
- Current engagement in psychotherapy
- Current pregnancy
- Significant medical issues interfering with yoga practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga practice90-minute group yoga classes twice weekly for 12 weeks. | Behavioural | Yoga practice |
| Education90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules. | Behavioural | Education |
Primary outcome
Change in Beck Depression Inventory-II score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
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.
6 secondary outcomes
Change in Perceived Stress Scale score
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Change in methylation of the GrimAge epigenetic clock
Time frame: Baseline and 12 weeks
Change in transcription of the nuclear factor kappa-B (NF-κB) pathway
Time frame: Baseline and 12 weeks
Change in plasma interleukin-6 (IL-6) level
Time frame: Baseline and 12 weeks
Change in telomere length of leukocytes
Time frame: Baseline and 12 weeks
Change in plasma brain-derived neurotropic factor (BDNF) level
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Background: PubMed 28301561Prathikanti 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.
- Background: PubMed 37032928Wu 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.
- Background: PubMed 27174729Naveen 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.
- Background: PubMed 26677763Deng 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.
- Background: PubMed 31141465Nugent 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.
- Background: PubMed 31675136Pisanu 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.
- Background: PubMed 33820909Protsenko 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.
- Background: PubMed 29614706Tolahunase 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.
- Background: PubMed 32849047Venditti 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.
- Individual participant dataSharing planned: No
Related trials for Depression Mild
Active, not recruiting
Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
Hormone Care, Mild Depression
RecruitingPhase 2
Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Working Memory, Mild to Moderate Depression
Recruiting
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Depression, Depression Disorder
Recruiting
Social Prescribing for a Mindful Lifestyle
Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness
Not yet recruiting
Thrive at Home: A Virtual Reality Social Intervention for Older Adults
Mental Health (Depression), Mental Health and General Well-being
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sudha Prathikanti, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga practice and Education in people with Depression Mild and Depression Moderate, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sudha Prathikanti, MD (415-516-3867, sudha.prathikanti@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Depression Inventory-II score (time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091527, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.