Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Registration Number
- CTRI/2009/091/000129
- Lead Sponsor
- Emcure Pharmaceuticals Limited Pune
- Brief Summary
This is a prospective, randomized, open-label, multi-centric, comparative clinical trial being conducted to evaluate the efficacy, safety and tolerability of Desvenlafaxine succinate extended release (ER) tablet and its comparison with Venlafaxine hydrochloride extended release (ER) in the management of Major Depressive Disorder (MDD). Total 200 patients (100 per group) will be enrolled in this study. Study population will comprise of subjects with moderate and severe depression with Hamilton Rating Scale for Depression (HAM-D) of more than 17; routinely visiting clinics / hospitals of the investigators at the trial sites for management of the same. The starting dose of Desvenlafaxine succinate ER will be 50 mg once daily. If the patient does not improve in depression scores in the first 2 weeks, the dose will be increased to 100 mg once daily in case the need arises. The starting dose of Venlafaxine hydrochloride ER 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. Duration of therapy will be for minimum 60 days followed by 2 weeks of taper period. Primary efficacy outcome will be 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. Secondary efficacy outcome will be improvement in depression as assessed by the change in Montgomery-Asberg Depression rating Scale (MADRS) from the baseline till the end of 2 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject of either sex and age between 18-65 years2.Subject with Major Depressive Disorder of at least 4 weeks' duration 3.Subject with Hamilton rating score for depression more then 17.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 0,15,30,45,60 days
- Secondary Outcome Measures
Name Time Method Improvement in depression as assessed by the change in Montgomery-Asberg Depression rating Scale (MADRS) from the baseline till the end of 2 months. 0,15,30,45,60 days
Trial Locations
- Locations (11)
Dr. Abhay Paliwal
🇮🇳Indore, MADHYA PRADESH, India
Dr. Hemang Desai
🇮🇳Ahmadabad, GUJARAT, India
Dr. Sanjay Phadke
🇮🇳Pune, MAHARASHTRA, India
Dr. Ujwal Sardesai
🇮🇳Indore, MADHYA PRADESH, India
Dr. Umesh Nagapurkar
🇮🇳Showroom,Sharanpur, India
Healthy Mind Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Jeswani Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Manovedh Clinic
🇮🇳Station, India
Saoji-Tupkari Hospital
🇮🇳Aurangabad, BIHAR, India
Shanti Nursing Home
🇮🇳Aurangabad, BIHAR, India
Scroll for more (1 remaining)Dr. Abhay Paliwal🇮🇳Indore, MADHYA PRADESH, IndiaDr Abhay PaliwalPrincipal investigator09826044402abhaypaliwal@yahoo.com