Comparison of efficacy and safety of Vortioxetine and Escitalopram in depressive patients.

Not Applicable

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

• Registration Number: CTRI/2023/12/060661
• Lead Sponsor: Ronakkumar Chandubhai Patel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All patients giving written consent will be taken.

Subjects >18 & <60 years of age of either gender, diagnosed to be suffering from depression as per ICD-10 (International classification of Diseases) with or without somatic symptoms or recurrent depressive disorder as per ICD- 10 with or without somatic symptoms, duration of current depressive episode is to be between 4 weeks to 12 months, and scoring =7 and = 34 on MADRS (Montgomery Asberg Depression Rating scale), 12 CGI-S (Clinical global impression) >2 and <6 on the initial visit will be enrolled in the study.

Exclusion Criteria

Current or past comorbid diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, a psychotic disorder not otherwise specified, mood-congruent or mood-incongruent psychotic features, bipolar disorder, alcohol or substance-use disorder, organic mental disorder including dementia, eating disorder, or obsessive compulsive disorder; presence of a seizure disorder; previous treatment with electroconvulsive therapy; currently pregnant/lactating women; and risk of suicide. • All patients with an unclear history of antidepressant treatment. Patients not giving informed consent. Patients scoring =6 on MADRS items number 10 (suicidal thoughts) at screening or baseline, history of non response to an adequate (6 week) trial of three or more antidepressant (with or without mood stabilizers) during the current episode, with imminent risk of suicide or injury to self, others, or property.

Besides, patients with current clinically significant neurological, metabolic (including typel diabetes), hepatic, renal, hematological, pulmonary. cardiovascular, gastrointestinal, and/or urological disorder such, as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study subjects with human immunodeficiency virus (HIV) seropositivity (or history of seropositivity), history of malignancy, or any chronic incapacitating illness will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified