A Post marketing study to see safety and efficacy of combination of Amitriptyline and Chlordiazepoxide in management of depression with co-morbid anxiety

A Prospective, single arm, Multi-centric, Active, Post Marketing Surveillance Study for evaluation of safety and efficacy of FDC of Amitriptyline and Chlordiazepoxide tablets of Dr. Reddys Laboratories Ltd in management of depression with co-morbid anxiety

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/03/031971

Enrollment

375

Registered

2021-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: F419- Anxiety disorder, unspecified

Interventions

Intervention1: Libotryp tablets and Libotryp DS tablets: Combination of Amitriptyline 12.5 mg or 25mg and Chlordiazepoxide 5 mg or 10 mg Chlordiazepoxide and amitriptyline hydrochloride tablets 10

Eligibility

Inclusion criteria

Inclusion criteria: Patient with anxiety comorbid with depression Newly Prescribed with Libotryp or Libotryp DS as per clinical discretion of investigator

Exclusion criteria

Exclusion criteria: Patients who is not able to understand the nature of study and willing to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
To actively surveil safety of FDC of Amitriptyline and Chlordiazepoxide tablets in management of depression with co-morbid anxiety in India in terms of Sedative effects and Anticholinergic side effects and Dizziness and Decrease in LibidoTimepoint: Incidence of any of the following event Sedative effects or Anticholinergic side effects or Dizziness or Decrease in Libido or AE or SAE at Day 30 and Day 60 after study using study medication	—

Measure

Time frame

To actively surveil safety of FDC of Amitriptyline and Chlordiazepoxide tablets in management of depression with co-morbid anxiety in India in terms of Sedative effects and Anticholinergic side effects and Dizziness and Decrease in LibidoTimepoint: Incidence of any of the following event Sedative effects or Anticholinergic side effects or Dizziness or Decrease in Libido or AE or SAE at Day 30 and Day 60 after study using study medication

—

Secondary

Measure	Time frame
To passively evaluate Safety reports such as adverse drug reactions, laboratory parameters, ECG (if available) To evaluate Efficacy as change in Hamilton Anxiety Score (HAM-A) and Hamilton Depression Score (HAM-D) score Timepoint: Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 30 days of therapy 2. Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 60 days of therapy	—

Measure

Time frame

To passively evaluate Safety reports such as adverse drug reactions, laboratory parameters, ECG (if available) To evaluate Efficacy as change in Hamilton Anxiety Score (HAM-A) and Hamilton Depression Score (HAM-D) score Timepoint: Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 30 days of therapy 2. Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 60 days of therapy

—

Countries

India

Contacts

Public ContactAmey Mane

Head Ideation and Clinical Research

amey.mane@drreddys.com

Outcome results

None listed

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