A Prospective, randomized, active-controlled, Comparative, Open-Label, parallel group, 2-arm, Multi-centric, Phase IV trial for evaluation of efficacy and safety of FDC of Amitriptyline and Chlordiazepoxide tablets of Wockhardt Limited versus Amitriptyline alone in management of depression with co-morbid anxiety.

Wockhardt Ltd0 sites0 target enrollmentTBD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: null- Depression with co-morbid anxietyHealth Condition 2: F418- Other specified anxiety disorders
Sponsor: Wockhardt Ltd
Status: Suspended
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Wockhardt Ltd

•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

•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

Not specified