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Clinical Trials/CTRI/2014/08/004904
CTRI/2014/08/004904
Completed
Phase 4

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

Government Medical College0 sites70 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Government Medical College
Enrollment
70
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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