Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Escitalopram 5 mg/10 mg and Etizolam 0.5 mg in Subjects with Major Depressive Disorder with Associated Anxiety

Phase 4

Completed

• Conditions: Health Condition 1: F339- Major depressive disorder, recurrent, unspecified

• Registration Number: CTRI/2020/08/026974
• Lead Sponsor: Macsur Pharmaa I Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-12
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>Week 4 : Telephonic Visit. <br/ ><br>Week 8 : End of study. Data collection.

Secondary Outcome Measures

Name	Time	Method
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.