Health Condition 1: F339- Major depressive disorder, recurrent, unspecified
Conditions
Interventions
Intervention1: Escitalopram 5 mg/10 mg and Etizolam 0.5 mg: Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin)
Sponsors
Macsur Pharmaa I Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign informed consent form. Written informed consent must be obtained before any assessment is performed 2. Male and female subjects of aged 18 years to 75 years 3. Patients suffering from MDD with associated anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks. 4. Patients who are previously on SSRIs anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks. ïâ??· Patients who are previously on SSRIs
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to Escitalopram 5 mg/10 mg and Etizolam 0.5 mg or any excipients 2. Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments. 3. Known contraindication for the use of Escitalopram or Etizolam 4. Patients with serotonin syndrome 5. Should not be SSRI resistant (not responding to 4-6 weeks of SSRI previously) 6. Any other treatments such as fluoxetine (SSRI), other antidepressants, hienodiazepine, benzodiazepines, barbiturates, or �²-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication 7. Any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions. 8. A history of drug or alcohol abuse within the past 6 months 9. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study 10. Female who is pregnant, nursing, or of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the safety and efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practiceTimepoint: Day 1 : Screening/ Baseline Visit. Week 4 : Telephonic Visit. Week 8 : End of study. Data collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in patients with major depressive disorder associated with anxiety in regular clinical practiceTimepoint: The primary efficacy is evaluated by using Montgomery-Ã?â?¦sberg Depression Rating Scale (MADRS) at Week 8 and ïâ??· The secondary efficacy is evaluated by using Hamilton Depression Rating Scale17 (HAMD-17) at Week 8. | — |
Countries
India
Contacts
Public ContactMrVairamuthuAmmaiyappam
iDD Research Solutions Pvt ltd
Outcome results
None listed