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

Status Not yet recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depressive Disorder

• NCT number: NCT06091527
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Sudha Prathikanti, MD
• Phone: 415-516-3867
• Email: sudha.prathikanti@ucsf.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2023
• Completion date: December 2024