Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Vilazodone: Tab. Vilazodone will be started at a dose of 20 mg/day. If required, dose titration will be done up to 40 mg/day by the clinician. The treatment will be continued for a peri
Sponsors
N Simple Santi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with MDD 2. HDRS score > 24 at baseline 3. Patients willing to give written informed consent at baseline
Exclusion criteria
Exclusion criteria: 1. Patients with psychotic symptoms 2. Patients with a history of substance abuse 3. Pregnant or lactating women 4. Patient with a history of known adverse effect to the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of HDRS score by 15 units in at least 50% of participants in the study groupsTimepoint: Baseline, Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Blood glucose values (FBS)Timepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Change of CBC parametersTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Change of liver enzymes, bilirubin, and albumin levelsTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Change of quality of life (assessed by SF-36 questionnaire) in the study groupsTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Change of serum creatinine valuesTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Evaluation of adherence of study participants (by MMAS-8) of the study groupsTimepoint: Baseline, Week 8, and Week 16;Incidence of adverse events in the study participants during the study durationTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16;Proportion of participants achieving HDRS score less than 7Timepoint: Baseline, Week 8, Week 12, and Week 16;Reduction of CGI score in the study groupsTimepoint: Week 4, Week 8, Week 12, and Week 16;Reduction of HDRS score in the study groupsTimepoint: Baseline, Week 4, Week 8, and Week 12;Reduction of MADRS score in the study groupsTimepoint: Baseline, Week 4, Week 8, Week 12, and Week 16 | — |
Countries
India
Contacts
Public ContactN Simple Santi
Veer Surendra Sai Institute of Medical Science And Research, Burla
Outcome results
None listed