Treating Major Depression With Yoga Mono-therapy

• ClinicalTrials.gov Identifier: NCT06091527
• Recruitment Status: Not yet recruiting
• First Posted: October 19, 2023
• Last Update Posted: October 19, 2023
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: October 13, 2023
• First Posted Date: October 19, 2023
• Last Update Posted Date: October 19, 2023
• Estimated Study Start Date: November 2023
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 13, 2023)

Reduction in Beck Depression Inventory-II score [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 13, 2023)

• Reduction in Perceived Stress Scale score [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks ]
  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.
• Reduction in methylation of the GrimAge epigenetic clock [ Time Frame: Baseline and 12 weeks ]
  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.
• Reduction in transcription of the nuclear factor kappa-B (NF-κB) pathway [ Time Frame: Baseline and 12 weeks ]
  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-κB) 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.
• Reduction in serum interleukin-6 (IL-6) level [ Time Frame: Baseline and 12 weeks ]
  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.
• Increase in telomere length of leukocytes [ Time Frame: Baseline and 12 weeks ]
  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.
• Increase in serum telomerase level [ Time Frame: Baseline and 12 weeks ]
  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.
• Increase in serum brain-derived neurotropic factor (BDNF) level [ Time Frame: Baseline and 12 weeks ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treating Major Depression With Yoga Mono-therapy
• Official Title: Treating Major Depression With Yoga Mono-therapy: 12-Week Randomized Controlled Trial
• Brief 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.
• 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 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Depression Mild
• Depression Moderate

Intervention

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

Study Arms

• Experimental: Yoga practice
  Yoga practice groups
  Intervention: Behavioral: Yoga practice
• Active Comparator: Education
  Education module group
  Intervention: Behavioral: Education

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 13, 2023): 180
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sudha Prathikanti, MD; 415-516-3867; sudha.prathikanti@ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06091527
• Other Study ID Numbers: 23-38755
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sudha Prathikanti, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2023