Study on Vortioxetine vs Fluoxetine in the treatment of Depressio

Phase 4

Not yet recruiting

Conditions: Health Condition 1: F33- Major depressive disorder, recurrentHealth Condition 2: F32- Major depressive disorder, singleepisode

Registration Number: CTRI/2023/09/057558

Lead Sponsor: Government Medical College and Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the severity of psychiatric symptomatology as measured by HDRS-17, CGI-S and CGI-ITimepoint: 0,2,4,6,10 weeks

Secondary Outcome Measures

Name	Time	Method
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