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

Phase 4

Completed

• Conditions: Health Condition 1: F339- Major depressive disorder, recurrent, unspecified

• Registration Number: CTRI/2020/07/026583
• Lead Sponsor: Macsur Pharmaa I Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-10-14
• 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. Written informed consent must be obtained before any assessment is performed.

2. Male and female subjects of aged 18 years to 75 years.

3. Na�¯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.

4. Newly prescribed with Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg as per the investigators discretion.

Exclusion Criteria

1. Hypersensitivity to Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg or any excipients.

2. Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments.

3. Known contraindication for the use of Amitriptyline or Chlordiazepoxide.

4. any other treatments such as SSRIs, other antidepressants, thienodiazepines, benzodiazepines, barbiturates, or �²-blockers potentially resulting in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.

5. any medical (eg, cardiac, liver, renal, endocrinologic, neoplastic, pulmonary) or neurologic (eg, bipolar disorder, schizophrenia) disease and other clinical conditions.

6. A history of drug or alcohol abuse within the past 6 months.

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

8. 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
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.Timepoint: 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, <br/ ><br> telephonic visit (Week 4) <br/ ><br> 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 practiceTimepoint: 1.The primary efficacy is evaluated by using Montgomery-Ã?â?¦sberg Depression Rating Scale (MADRS) at Week 8. <br/ ><br> <br/ ><br> 2.The secondary efficacy is evaluated by using Hamilton Depression Rating Scale17 (HAMD-17) at Week 8.