Health Condition 1: F339- Major depressive disorder, recurrent, unspecified
Conditions
Interventions
Intervention1: Amitriptyline 12.5mg/25mg and Chlordiazepoxide 5mg/10mg: The investigational drug is a fixed dose Amitriptyline and Chlordiazepoxide.This product contains 2 medicines (amitriptyline, c
Sponsors
Macsur Pharmaa I Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, telephonic visit (Week 4) End of study Visit (EOS) at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| "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"Timepoint: 1.The primary efficacy is evaluated by using Montgomery-Ã?â?¦sberg Depression Rating Scale (MADRS) at Week 8. 2.The secondary efficacy is evaluated by using Hamilton Depression Rating Scale17 (HAMD-17) at Week 8. | — |
Countries
India
Contacts
Public ContactMrVairamuthuAmmaiyappam
iDD Research Solutions Pvt ltd
Outcome results
None listed