Health Condition 1: F33- Major depressive disorder, recurrent Health Condition 2: F32- Major depressive disorder, singleepisode
Conditions
Interventions
Intervention1: Vortioxetine: - Anti-depressant drug
- Dose range: 10-20 mg per day based on response to drug
- Frequency: Daily
- Route: Oral
- Follow up at 2 weeks, 4 weeks, 6 weeks and 10 weeks.
-
Sponsors
Government Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with Single Episode Depressive Disorder or Recurrent Depressive Disorder (as per criteria in ICD-11) 2. Drug naïve patients or patients not on treatment with anti-depressants for a duration of 4 weeks for Fluoxetine and 1 week for other anti-depressants 3. Persons of any gender 4. Age – 18 to 60 years 5. Level of Education – 10th Pass 6. Providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with psychiatric comorbidities like Bipolar Affective Disorder, Psychosis, Generalized Anxiety Disorder, OCD. 2. Patients with comorbid substance dependence (except nicotine and caffeine) 3. Patients with neurological disorders – Dementia, Parkinsonism, Tumors, Epilepsy and Organic brain damage 4. Actively suicidal patients 5. Patients who are pregnant or lactating 6. Patients with Intellectual Disability 7. Patients on anti-psychotics, anticholinergics and mood stabilizers 8. Patients receiving Cognitive Behavioral Therapy, Cognitive Enhancement Therapy or any other psychological treatments in the last 6 weeks 9. Patients who have received Electroconvulsive Therapy in last 3 months 10. Patients having depression secondary to medical illness 11. Patients with known history of hypersensitivity/ allergic reaction to Vortioxetine or Fluoxetine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the severity of psychiatric symptomatology as measured by HDRS-17, CGI-S and CGI-ITimepoint: 0,2,4,6,10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of treatment on neuro-cognitive functions and hematological parameters as measured on Digit Symbol Substitution Test, Trail Making Test, Digit Span Test, H-MoCA, ASEX and hematological investigationsTimepoint: 0,2,4,6,10 weeks | — |
Countries
India
Contacts
Public ContactGeeteshwar Dewan
Government Medical College and Hospital, Sector 32, Chandigarh
Outcome results
None listed