Treating Major Depression With Yoga Mono-therapy

Depression Mild Clinical Trial

Official title:

Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091527
• Other study ID #: 23-38755
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Sudha Prathikanti, MD
• Phone: 415-516-3867
• Email: sudha.prathikanti[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single-center, single-blind, randomized, controlled, parallel group, interventional trial 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 a an education control intervention on holistic healthcare.

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 severity: methylation of the GrimAge epigenetic clock, nuclear factor kappa-B (NF-κB) transcription, leucocyte telomere length, and serum levels of telomerase, 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 reduction 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: reduction in PSS scores, reduction in methylation of the GrimAge epigenetic clock, reduction in NF-κB transcription, reduction in serum IL-6, increase in leucocyte telomere length, increase in serum telomerase, and increase in serum BDNF. In sub-analyses, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older
• All gender identities
• All ethnicities
• Able to give voluntary, informed consent
• English proficiency sufficient for study participation
• Living near San Francisco during study, and able to attend all required visits for study participation
• Clinical diagnosis of major depression per screening Mini International Neuro-psychiatric Interview
• Depression symptoms of mild to moderate severity, per score of 14-28 on screening Beck
• Depression Inventory-II

Exclusion Criteria:

• Use of antidepressant medication during the study period, or during the 2 months prior to study period (at screening, individuals who report being in treatment with antidepressant medication will not be asked to discontinue medication; instead, these individuals will be excluded from study participation)
• Use of psychotherapy during the study period (at screening, individuals who report being in psychotherapy will not be asked to discontinue psychotherapy; instead, these individuals will be excluded from study participation)
• Use of any yoga exercises, other than study intervention, during the study period
• Cognitive Impairment (score < 24 on screening Folstein Mental Status Exam)
• Diagnosis of active substance use disorder currently or during the 2 months prior to screening interview
• Diagnosis of bipolar disorder or any other serious mental illness, other than major depression, per screening Mini International Neuro-psychiatric Interview
• Severe major depression, per score > 28 on screening Beck Depression Inventory-II
• History of suicide attempts, suicidal ideation, or psychosis
• Pregnancy
• Seizure disorder
• Carotid artery stenosis
• Uncontrolled hypertension
• Severe pulmonary disease
• Severe musculoskeletal problems likely to interfere with 12 weeks of study participation.
• Other medical conditions with acute somatic or constitutional symptoms (such as fever, vertigo, nausea, severe fatigue, severe pain) present at the time of screening and likely to interfere with 12 weeks of study participation.

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depressive Disorder

Intervention

Behavioral:
• Yoga practice
90-minute group yoga classes twice weekly for 12 weeks.
• Education
90-minute group education classes twice weekly for 12 weeks to learn holistic healthcare modules.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Beck Depression Inventory-II score	The BDI 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 BDI 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 BDI 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	Reduction 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 originally developed by Cohen et al in 1983. It is widely 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.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks
Secondary	Reduction in methylation of the GrimAge epigenetic clock	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The methylation level of the GrimAge epigenetic clock will be measured in a specimen of whole blood that has been collected in acid citrate dextrose (ACD) yellow top tube. The estimated blood volume needed is 8.5 ml per participant and measurement.	Baseline and 12 weeks
Secondary	Reduction in transcription of the nuclear factor kappa-B (NF-?B) pathway	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The transcription level of the nuclear factor kappa-B (NF-?B) pathway will be measured in a specimen of whole blood that has been collected in a PAXgene tube with reagent for stabilization of intracellular RNA. The estimated blood volume needed is 2.5 ml per participant and measurement.	Baseline and 12 weeks
Secondary	Reduction in serum interleukin-6 (IL-6) level	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The serum level of Interleukin-6 (IL-6) will be measured in a specimen of whole blood that has been collected in a Serum Separator Tube (SST) Gold Top vs plain Red Top. The estimated blood volume needed is 6-7 ml per participant and measurement.	Baseline and 12 weeks
Secondary	Increase in telomere length of leukocytes	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The telomere length of leukocytes will be measured in a specimen of whole blood that has been collected in a EDTA anticoagulant Lavender top tube. The estimated blood volume needed is 3 ml per participant and measurement.	Baseline and 12 weeks
Secondary	Increase in serum telomerase level	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The serum telomerase level will be measured in a specimen of whole blood that has been collected in a EDTA anticoagulant Lavender top tube. The estimated blood volume needed is 3 ml per participant and measurement.	Baseline and 12 weeks
Secondary	Increase in serum brain-derived neurotropic factor (BDNF) level	Blood samples will be drawn from each enrolled participant at the Baseline Visit and at 12 weeks. The serum level of brain-derived neurotropic factor (BDNF) will be measured in a specimen of whole blood that has been collected in Serum Separator Tube (SST) Gold Top vs plain Red Top. The estimated blood volume needed is 6-7 ml per participant and measurement.	Baseline and 12 weeks