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Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder

A Prospective, Open label, Randomized, Comparative, Multicentric trial to evaluate the Efficacy and Safety of Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000129
Enrollment
Unknown
Registered
2009-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Major Depressive Disorder

Interventions

Intervention1: Desvenlafaxine succinate: Desvenlafaxine succinate extended release (ER) available as 50 mg and 100 mg tablets for oral administration. Dose- The starting dose will be 50 mg once daily.
The starting dose will be 75 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 150 mg once daily. Total duration of therapy will b

Sponsors

Emcure Pharmaceuticals Limited Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject of either sex and age between 18-65 years 2. Subject with Major Depressive Disorder of at least 4 weeks' duration 3. Subject with Hamilton rating score for depression more then 17

Exclusion criteria

Exclusion criteria: 1. Patient with features of psychosis 2. Subjects with bipolar disorder 3. Concomitant use of other antidepressants 4. Endocrine disease other than Type 2 diabetes 5. Hypersensitivity to Venlafaxine or Desvenlafaxine 6. History of arrhythmias 7. History of congestive heart failure 8. History of coronary artery disease 9. History of stroke 10. Severe hypertension 11. Liver impairment 12. Narrow angle glaucoma 13. Untreated hypothyroidism or hyperthyroidism 14. Pulmonary hypertension 15. Renal impairment 16. History of seizures 17. Alcohol abuse 18. Psychoactive substance abuse 19. Recent tobacco cessation 20. Lactating or pregnant women 21. Any condition that, in the opinion of the investigator, does not justify the subjects? inclusion in the study

Design outcomes

Primary

MeasureTime frame
Improvement in depression as assessed by the change in Hamilton Rating Scale for Depression (HAM-D) from the baseline till the end of 2 months.Timepoint: 0,15,30,45,60 days—

Secondary

MeasureTime frame
Improvement in depression as assessed by the change in Montgomery-Asberg Depression rating Scale (MADRS) from the baseline till the end of 2 months.Timepoint: 0,15,30,45,60 days—

Countries

India

Contacts

Public ContactDr Onkar Swami

Manager- Medical

Onkar.Swami@emcure.co.in02039821000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026