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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

An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Desvenlafaxine Succinate Equivalent to Desvenlafaxine 100mg/50mg and Clonazepam 0.5 mg/0.5mg uncoated bilayered tablet in Major Depressive Disorder with Co-Morbid Anxiety

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/033076
Enrollment
200
Registered
2021-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F41- Other anxiety disorders

Interventions

Intervention1: Desvenlafaxine 100mg/50mg and Clonazepam 0.5 mg/0.5mg uncoated bilayered tablet: Desvenlafaxine and Clonazepam. Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI) wh

Sponsors

GKM New Pharma
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactMr Vairamuthu Ammaiyappan

iDD Research Solutions INC

yogesh@iddresearch.com8520082152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026