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Yoga, Ayurveda and Escitalopram for Depression: A feasibilty trial with biomarker profiling

Pilot Feasibility of a Sequential Multiple Assignment Randomised Trial (SMART) Design for Depression: Integrating Yoga, Ayurveda, Escitalopram, and Biomarker Profiling - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094932
Enrollment
73
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F330- Major depressive disorder, recurrent, mild Health Condition 2: F331- Major depressive disorder, recurrent, moderate Health Condition 3: F320- Major depressive disorder, singleepisode, mild Health Condition 4: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Yoga: A specific yoga module of 1 hour duration, 6 days a week is delivered for patients with depression for a duration of 4 to 12 weeks (depending on the randomised arm) Control Interv

Sponsors

Indian Council for Medical Research
Lead Sponsor
Collaborative Research Centre for MindBody Interventions through Yoga CCRYN NIMHANS collaboration
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with mild to moderate Depressive disorder (MDD or RDD)(HRDS score between 7 and 24) Without psychotic symptoms and without suicidality 2)Drug na ve for current episode or drug free for 4 weeks in the current episode 3)Comorbid anxiety disorder(s) are allowable if they do not interfere with participation 4)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Suicidal ideation with intent in the prior year (according to Columbia Suicide Severity Rating Scale) 2)Patients who have received structured specific yoga practices in the past 1 month 3)Already on ayurveda or Unani or homeopathy medications 4)Patients who had received ECT in past 3 months 5)History of bipolar disorder, schizophrenia, schizoaffective disorder, substance abuse or dependence (except tobacco), OCD 6)Any severe medical comorbidities 7)Pregnancy

Design outcomes

Primary

MeasureTime frame
The primary outcome is feasibility of the SMART design implementation across key domains.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary

MeasureTime frame
Trends in depressive symptom changes per treatment sequence, examining effect sizes and patternsTimepoint: Baseline, 4 weeks, 8 weeks, 12 weeks;Preliminary trends in biomarker measure changes (neurocognitive, HRV, GABA MRS, fMRI connectomes) related to treatment sequences and response.Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks

Countries

India

Contacts

Public ContactDr Daiveek PG

National Institute of Mental Health And Neurosciences (NIMHANS), Bengaluru

hollabharath@gmail.com9844259459

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026