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Study to check whether Escitalopram & Clonazepam combination is safe and effective in treatment of anxiety with depression and how they are used in that condition

A Retrospective, Observational, Case cohort, Multicenter Study to Assess the Safety, Effectiveness & Utilization of Escitalopram & Clonazepam FDC in the treatment of Co-morbid depression & Anxiety (RESET 2 study) - RESET 2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088599
Enrollment
10000
Registered
2025-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: F33- Major depressive disorder, recurrent Health Condition 2: F413- Other mixed anxiety disorders

Interventions

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients suffering from Co-morbid depression with anxiety treated with Escitalopram & Clonazepam FDC 2. Patients with HAM-A score more than or equal to 17 3. Patients with MADRS score more than or equal to 7 4. Patients followed-up for 12 weeks 5. Patients having at least 2 reported follow-up visits in 12 weeks following dose/therapy initiation [Baseline, Visit-1 & Visit-2 (Follow-up)].

Exclusion criteria

Exclusion criteria: 1. Cases with incomplete medical records 2. Any patients suffering from Treatment Resistant Depression (TRD)

Design outcomes

Primary

MeasureTime frame
- Occurrence of AE/SAE/Discontinuation from ESC-CZP FDC therapy - Change from baseline in HAM-A & MADRS scores from baseline to 4th week & 12th week. Timepoint: Baseline, 4 and 12 weeks

Secondary

MeasureTime frame
- Usage pattern for Escitalopram & Clonazepam FDC such as Sociodemographic data, Prevalence of co-morbid conditions and Usage pattern for co-prescribed drugs - Switching pattern to Escitalopram & Clonazepam FDCTimepoint: Baseline;- Adverse events reported at the end of the study - Clinical Global Impression for Efficacy Index (CGI-EI) at 12th weekTimepoint: 12 weeks

Countries

India

Contacts

Public ContactYakshdeep Dave

Torrent Pharmaceuticals Ltd.

zahraanqureshi@torrentpharma.com7069000629

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026