Study to Monitor the Safety and Efficacy of Combination Therapy of Desvenlafaxine Succinate Equal to Desvenlafaxine 100mg/50mg and Clonazepam 0.5 mg/0.5mg uncoated bilayered tablet in Major Depressive Disorder with Co-Morbid Anxiety

Phase 4

Completed

• Conditions: Health Condition 1: F41- Other anxiety disorders

• Registration Number: CTRI/2021/04/033076
• Lead Sponsor: GKM New Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-26
• 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.

2. Male and female patients of aged 18 years to 75 years with a primary diagnosis of MDD.

3. Patients prescribed with medication for co-morbid depression and anxiety.

4. Female patient of child-bearing age on medically acceptable contradiction, including oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception

Exclusion Criteria

1. Patients on selective Serotonin Reuptake Inhibitor drugs (SSRI) and Monoamine oxidase inhibitors (MAOIs) 90 days prior to screening

2. Clinically important abnormalities on screening, physical examinations, or use of prohibited treatments.

3. Any other condition as per investigatorââ?¬•s discretion.

4. Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study.

5. 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
Adverse events ïâ??· Treatment emergent adverse event (TEAEs) rates.Timepoint: Visit 1 (Screening/baseline visit on Day 0) <br/ ><br> <br/ ><br>Visit 2 (Telephonic visit (week 4) <br/ ><br> <br/ ><br>Visit 3[Site visit (End of study visit on week 8)]

Secondary Outcome Measures

Name	Time	Method
Change in score of Hamilton Depression Rating Scale-17 (HAMD-17)from the baseline to week 8 <br/ ><br> <br/ ><br>Change in Hamilton Anxiety Rating Scale-14(HAM-A) from the baseline to week 8 <br/ ><br> <br/ ><br>Assessment Global Impressions- Severity (CGI-S) score at week 8Timepoint: Visit 1 (Screening/baseline visit on Day 0) <br/ ><br>And <br/ ><br>Visit 3[Site visit (End of study visit on week 8)]