Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Desvenlafaxine and Clonazepam tablets

Not Applicable

Completed

Conditions: Major depressive disorder, recurrent, unspecified,

Registration Number: CTRI/2020/06/026111

Lead Sponsor: Akums Drugs and Pharmaceuticals Limited

Brief Summary: The fixed dose combination oral tablet ofDesvenlafaxine and Clonazepam is being marketed in India for the treatment of major depressive disorder.

The primary objective of this PMS is to evaluatesafety and tolerability of this FDC in treatment of major depressive disorder in the actual fieldconditions of use. The secondary objective of this PMS is to evaluate efficacy of this FDC in treatment of major depressive disorder in the actual fieldconditions of use.

All patientsclinically manifesting with symptoms of major depressive disorder and who have been prescribed Desvenlafaxine and Clonazepam TABLET in the recommended doses will be assessed for safety & efficacy.Patients will usually be called for follow-up on the day convenient tothem and will be judged on the bases of enquiry & clinician impression.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

1.Patients of either sex of age 18 to 60 years [both inclusive] 2.Willing to give written informed consent 3.All patients clinically manifesting with symptoms of major depressive disorder.

Exclusion Criteria

1)Patients known, or thought to be hypersensitivity to study drug 2)History of auto-immune disease 3)Concurrent use of corticosteroids 4)Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion 5)Participation in other clinical trials the last three months and during study participation 6)Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs 7)Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 8)Patients with galactose or fructose intolerance 9)Patients with severe renal impairment, including those receiving dialysis.
10)Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11)Patients with preexisting gallbladder disease 12)Active peptic ulcer disease.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this PMS is to evaluate safety and tolerability of this FDC in treatment of major depressive disorder in the actual field conditions of use.	4 Weeks

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this PMS is to evaluate efficacy of this FDC in treatment of major depressive disorder in the actual field conditions of use.	4 Weeks

Trial Locations

Locations (1): Hi Tech Medical College & Hospital
🇮🇳
Khordha, ORISSA, India
Hi Tech Medical College & Hospital
🇮🇳Khordha, ORISSA, India
Dr Amrit Pattojoshi
Principal investigator
7008690566
dramritpattojoshi@gmail.com