To assess the safety and effectiveness of vortioxeTine and escitalopram with clonazepam in anxious depressive patients

Phase 4

• Conditions: Health Condition 1: F418- Other specified anxiety disorders

• Registration Number: CTRI/2024/06/068554
• Lead Sponsor: TORRENT PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

Male or female patients 18 to 65 years with DSM-V defined MDD with anxious

depression.

Treatment naïve patients or known cases already on VOR or ESC not exceeding two weeks of active treatment.

? Patients with MADRS score is greater than 20 and HAM-A score is greater than 25.

Patient with normal physical examination clinical laboratory and ECG findings (as per

physicians discretion)

Patients who are willing to sign the informed consent form

Exclusion Criteria

Patient aged less than 18 years and more than 65 years will be excluded.

Patient with MADRS less than 19 and HAM-A less than 24.

Patients requiring second generation antipsychotics or lithium.

Patient in which the use of benzodiazepine is contraindicated.

Patient with other conditions who do not fit into the criteria of the study as per the

protocol.

Patient with known hypersensitivity to Vortioxetine, Escitalopram, Clonazepam or any

excipients.

Patients who are not willing to sign the informed consent form

Study & Design

• Study Type: Interventional
• Study Design: Not specified