Health Condition 1: null- Depression
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age group 18-60 years 2. Permanent residents living in the area of MCH unit Pangappara for at least past 6 months 3. Diagnosis of moderate to severe depression 4. Informed consent to participate in the trial , to record examination findings and use the data in research and future publication 5. Literacy to read and write in Malayalam 6. Have an active phone number
Exclusion criteria
Exclusion criteria: Past or current diagnosis or history of treatment for bipolar disorder, dementia, psychosis 2. Currently being managed by a psychiatrist or psychologist 3. Taking any psychotropic drug 4. High risk of suicidality as measured by a suicidality score above 17 5. Pregnant, breastfeeding or planning to become pregnant in next 6 months 6. Seriously ill or bedridden patient 7. A woman who is not able to communicate with the health worker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission of depression at 12 weeks as measured by 50% reduction in score from baseline in Hamilton Rating Scale for Depression ( HAM-D) or Montgomery Asberg Depression Rating Scale ( MADRS) or remission as per Mini Neuropsychiatric Interview (MINI) for DepressionTimepoint: 2 weeks, 4weeks, 8 weeks, 12 weeks Interim analysis will be done at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| acceptabilityTimepoint: 2,6,8,12 weeks;Clinical Global Impression for Change or Improvement ( CGI-C / CGI-I)Timepoint: 2,6,8,12 weeks;Clinical Global Impression for Severity (CGI-S) scoreTimepoint: 2, 6, 8 and 12 weeks Interim analysis will be done at 8 weeks;Improvement in suicidality scoreTimepoint: 2 weeks, 6 weeks, 8 weeks, 12weeks;modified Global Assessment of Functioning (mGAF) scoreTimepoint: 2,6,8,12 weeks;treatment adherenceTimepoint: 2,6,8,12 weeks | — |
Countries
India
Contacts
Govt Medical College, Trivandrum