Health Condition 1: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
J S Ayurveda College
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study potential participants must meet all of the following criteria Gender and Age Participants must be adult females or males aged 18 to 65 years inclusive and be treated as in and or outpatients Diagnosis Participants must have a primary diagnosis of Major Depressive Disorder MDD of moderate or severe severity as defined by clinician rating scales and clinical judgment according to DSM5 criteria Participants with active and current suicidality will be excluded Prior Treatment Status Participants need to agree to start a new bout of allopathic or Ayurvedic treatment in the current episode regardless of any previous treatments received during the current episode Informed Consent Participants must have the capacity to understand the study procedures and provide informed consent to participate They must also be willing to fully participate and adhere to the study protocol These criteria aim to ensure a homogenous study sample to enhance the reliability and generalizability of study findings Any deviation from these criteria will be carefully documented and justified
Exclusion criteria
Exclusion criteria: Individuals will be excluded from participation in this study if they meet any of the following criteria Severe Psychiatric Comorbidity Active Suicidality Substance Use Disorder Pregnancy or Breastfeeding Significant Medical or Neurological Conditions Communication Barriers These exclusion criteria are designed to minimize confounding variables and ensure that the study results are interpretable and generalizable to a population of individuals with MDD who are otherwise relatively healthy Any deviations from these criteria will be carefully documented and justified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will focus on changes in depressive symptom severity, measured using three validated rating scales: the Hamilton Depression Rating Scale (HAM-D), the Montgomery- sberg Depression Rating Scale (MADRS), and the Patient Health Questionnaire-9 (PHQ-9).The use of multiple scales enhances the reliability and validity of the assessment, providing a more comprehensive picture of symptom change. Statistical analyses comparing changes in scores across treatment groups will be conducted to determine the relative efficacy of each intervention.Timepoint: Assessments will be conducted at baseline, bi-weekly for the first eight weeks, and then monthly until the six-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| functional assessment and quality of life the fast clinical global impression cgi general assessment of functioning gaf and quality of life whoqolbref qlesqsf will be used to provide a detailed profile of functional status and disability this provides a patient centred perspective on treatment effectiveness complementing the clinician rated symptom severity measuresTimepoint: Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up;adverse events the incidence and severity of adverse events will be meticulously recorded throughout the study period using a standardized adverse event reporting system uku gase this will allow for a direct comparison of the safety profiles of allopathic and ayurvedic treatmentsTimepoint: Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up;treatment adherence treatment adherence will be assessed using the medication adherence report scale mars5 supplemented by clinical judgmentTimepoint: Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up;patient satisfaction patient satisfaction with treatment will be evaluated using a validated patient satisfaction questionnaire these measures will assess the acceptability and feasibility of each treatment approachTimepoint: Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up;daily functioning changes in daily functioning will be assessed using the global assessment of functioning gaf scale and the functional assessment short test fast it provides a quantitative measure of functional capacity in various domains eg social occupational and selfcare reflecting the impact of depression on daily life and the extent of functional recoveryTimepoint: Assessments will be conducted at baseline bi-weekly for the first eight weeks a | — |
Countries
India
Contacts
Public ContactProf Dr Manishkumar Vadilal Patel
JS Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital
Outcome results
None listed