Comparison of efficacy and safety of agomelatin and escitalopram in patients of major depressive disorder.

A comparative study of the clinical efficacy and safety of agomelatine 25 mg (or 50 mg) with escitalopram 10 mg (or 20 mg) in major depressive disorder patients:a 24 weeks randomized open label parallel group study. - RACE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004904

Enrollment

Registered

2014-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- major depressive disorder patients

Interventions

Intervention1: AGOMELATIN: Melatonergic(MT1 and MT2 receptor agonist) and 5HT2c antagonist used in major depression. Dosage form - Tablet Dose - 25 mg Frequency - once a day at night or if no signifi

Eligibility

Inclusion criteria

Inclusion criteria: i) Age should be between 18-65 years with normal liver function. ii) Patient should be newly diagnosed of Major Depressive Disorder(MDD)-Patient who first time consult psychiatrist for the complaints suggestive of Major Depressive Disorder(MDD). iii) Patient is willing to give written informed consent.

Exclusion criteria

Exclusion criteria: i) Pregnant and Nursing Women ii)Patientâ??s on other antidepressants. iii)Patient with high risk of suicide or previous suicide attempt within 6 months, bipolar disorder, anxiety symptoms such as panic attacks, obsessive-compulsive disorder, posttraumatic stress disorder, drug abuse or dependency, previous depression resistant to antidepressants, and treatment with electroconvulsive therapy within 3 months or formal psychotherapy within 1 month. iv)Patient with neurologic disorders (dementia, seizures, stroke), obesity with functional impairment, serious or not stabilized organic disorders (neoplasia, cardiovascular, pulmonary, uncontrolled type 1 or 2 diabetes) v)Patient with â??resistant depressionâ?? defined as patients who have not responded to two different previous antidepressant treatment for at least four weeks at an appropriate dose.[9] v)Shift workers, women without effective contraception

Design outcomes

Primary

Measure	Time frame
to compare the clinical efficacy of Agomelatine with Escitalopram in the treatment of major depressive disorder.Timepoint: Total duration :- 24 weeks with follow up at 2nd week then 6th week, 10th week, 14th week, 18th week, 22th week and 24th week	—

Secondary

Measure	Time frame
to study the adverse drug effects profile of AgomelatineTimepoint: 24 weeks	—

Countries

India

Contacts

Public ContactDr PRASHANT TIPLE

Government medical college, Medical square, Nagpur

drsunil_mm@rediffmail.com919422812306

Outcome results

None listed

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