An Open Label, Multicentre Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice

Not Applicable

Completed

Conditions: Major depressive disorder, recurrent, unspecified,

Registration Number: CTRI/2020/07/026583

Lead Sponsor: Macsur Pharmaa I Pvt Ltd

Brief Summary: **Title of Study:** An Open Label, Multicentre, Post-Marketing Surveillance study to Monitor the Safety and Efficacy of Combination Therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in Subjects with Major Depressive Disorder with Associated Anxiety in Regular Practice

**Name of Study Therapy:** Major Depressive Disorder with Associated Anxiety

**Study Rationale:**This study is designed to assess the safety and efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in subjects with major depressive disorder associated with anxiety. The study was conducted to meet a regulatory requirement of Central Drugs Standard Control Organisation (CDSCO) in India for market authorization.

**Study design:** This will be an open-label, multi-center, post-marketing surveillance study to evaluate the newly prescribed safety and efficacy of fixed dose combination (FDC) of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in subjects with major depressive disorder with associated anxiety. A total of approximately 200 male and female subjects will be enrolled in 4 centers in India. For each enrolled subject, there will be a 1-day Screening/Baseline visit on Day 1, followed by a telephonic visit (Week 4) and End of study Visit (EOS) at Week 8. On the Day of Screening/Baseline, the medical history will be reviewed and study eligibility according to the inclusion and exclusion criteria will be confirmed. Eligible subjects will receive the combination therapy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg once a day, on Day 1 (Baseline visit), at their investigatorâ€™s discretion. Following a single oral dose of combination of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg, safety and efficacy assessments will be performed and data will be collected at the clinic visits. Subjects are followed up by their investigator during the telephonic visit at Week 4 and at the EOS (Week 8) to collect the subject data according to clinical need. Subjects will be instructed to report any adverse events (AE)/serious adverse event (SAE) within the course of the study. Data in a routine clinical monitoring of subjects are collected in the paper case report form (CRF). ECG details (if done) by investigator will be recorded in CRF. Safety assessments will include adverse event, serious adverse event monitoring and physical examinations.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

Willing and able to sign informed consent form.
Written informed consent must be obtained before any assessment is performed.
Male and female subjects of aged 18 years to 75 years.
NaÃ¯ve patients suffering from MDD with associated anxiety for at least 10 to 12 weeks as defined by DSM IV for at least 2 weeks.
Newly prescribed with Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg as per the investigators discretion.

Exclusion Criteria

Hypersensitivity to Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg or any excipients.
Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments.
Known contraindication for the use of Amitriptyline or Chlordiazepoxide.
any other treatments such as SSRIs, other antidepressants, thienodiazepines, benzodiazepines, barbiturates, or Î²-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.
A history of drug or alcohol abuse within the past 6 months.
Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the safety and efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder associated with anxiety in regular clinical practice.	To demonstrate the safety and efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder. Screening/Baseline visit on Day 1, \| telephonic visit (Week 4) \| End of study Visit (EOS) at Week 8

Secondary Outcome Measures

Name	Time	Method
"To demonstrate the efficacy of Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg in patients with major depressive disorder associated with anxiety in regular clinical practice"	1.The primary efficacy is evaluated by using Montgomery-Ã…sberg Depression Rating Scale (MADRS) at Week 8.

Trial Locations

Locations (3): Ishwar Institute of Health Science Padegaon
🇮🇳
Aurangabad, MAHARASHTRA, India
Medstar Speciality Hospital
🇮🇳
Bangalore, KARNATAKA, India
Udyaan Healthcare
🇮🇳
Lucknow, UTTAR PRADESH, India
Ishwar Institute of Health Science Padegaon
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Amol Deshmukh
Principal investigator
9823860018
ishwarhealthcare@gmail.com