Health Condition 1: null- Depression with co-morbid anxiety Health Condition 2: F418- Other specified anxiety disorders
Conditions
Interventions
Intervention1: Libotryp and Libotryp DS tablets: Libotryp tablets (FDC of
Amitriptyline 12.5 mg and
Chlordiazepoxide 5 mg) and
Libotryp DS tablets (FDC of
Amitriptyline 25 mg and Chlordiazepoxide 10 m
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject with all of the following would be included in the study: 1. Patients with clinical diagnosis of depression with co-morbid anxiety (Depression Score: More than or equal to 8 and anxiety Score: 0 â?? 56) on Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) respectively. 2. Patients or LAR who understand the nature of the trial and provide written informed consent for trial 3. Subjects who are willing to comply with protocol procedures
Exclusion criteria
Exclusion criteria: Subject with any of the following would be excluded from the study: 1. Patients with proven hypersensitivity to any of the contents of study medication i.e. Amitriptyline and Chlordiazepoxide. 2. Patients who, in the investigatorâ??s opinion, pose a risk for suicide/suicidal tendency 3. Patients with history of neuroleptic malignant syndrome due to any tricyclic antidepressants 4. History of any neurological disease including but not limited to stroke, tumor, seizure disorder history of brain trauma, chronic infection or a dementing illness or any psychotic disorder including but not limited to schizophrenia, delusional disorder or organic brain syndrome. 5. Significant Hepatic and/ or Renal insufficiency 6. Patient with known history of or currently suffering from Cardiac arrhythmia or conduction abnormality including but not limited to sinus tachycardia and prolongation of conduction time (Screening QTcB or QTcF > 450 msec). 7. Patient with known history of urinary retention due to organic failure 8. Patient with history of Myocardial Infarction (MI) or is in acute recovery phase of MI. 9. Patient who used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study 10. Patients who have received an antipsychotic or a benzodiazepine for at least 7 days prior to enrolment into the study 11. Pregnant or lactating females. 12. Patients who are alcoholics or having withdrawal symptoms of alcohol 13. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores.Timepoint: At end of 45 days of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), abnormal laboratory values, Clinical findingsTimepoint: Throughout the treatment period;Mean change in Depression and anxiety scores from baseline using Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A)Timepoint: At end of 45 days of therapy | — |
Countries
India
Contacts
Public ContactMr Ashish Mane
Wockhardt Ltd
Outcome results
None listed