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"Evaluating the Efficacy and Safety of Vortioxetine vs. Escitalopram in Treating Depressive Disorder: A Comparative Study"

A comparative study to assess the efficacy and safety of Vortioxetine versus Escitalopram in patients suffering from Depressive Disorder. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068969
Enrollment
120
Registered
2024-06-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Vortioxetine (10mg-20mg) Oral: 1. Patients will be assessed by DSST (executive function, speed of processing, attention), Trail Making Test A/B (TMT-A: speed of processing
TMT-B: executive function), Stroop test (congruent and incongruent: executive function) at baseline, week 4 and week 8. 2. Patients will be assessed using the Arizona Sexual Experiences Scale (ASEX) a

Sponsors

Himshikha Srivastava
Lead Sponsor
Alok Gupta
Collaborator
Bijay Kumar Prusty
Collaborator
Kritika Agarwal
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both male and female patients aged between 18 and 60 years. 2. Those giving written consent/guardians giving written consent (in cases where the patients were too ill to understand the process of informed consent and give an informed choice.) 3. People diagnosed with the depressive disorder as per ICD-11 diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1. Systemic or Neurological Disorder affecting Cognition, Behavior or Mental Status. 2. Substance dependence except for Nicotine and Caffeine within the past month of entering the study. 3. Long-standing medical or surgical illnesses. 4. Patients with mental retardation or organic brain disorders. 5. Patients suffering from neurological, metabolic and vascular conditions affecting sexual function. 6. Patients with sexual dysfunction at baseline were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Vortioxetine will be more efficacious on symptom severity in patients suffering from Depression compared to Escitalopram.Timepoint: At the end of 4 weeks and 8 weeks.

Secondary

MeasureTime frame
Vortioxetine and Escitalopram will have similar side effects.Timepoint: At the end of 4 weeks and 8 weeks.;Vortioxetine and Escitalopram will have similar effects on cognitive functioning.Timepoint: At the end of 4 weeks and 8 weeks.;Vortioxetine will be safer as compared to Escitalopram in sexual functioning.Timepoint: At the end of 4 weeks and 8 weeks.

Countries

India

Contacts

Public ContactMridul Deepanshu

IMS & SUM Hospital

drjbiswal@gmail.com9337270395

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026