Desvenlafaxine succinate ER tablet in the Management of Major Depressive Disorder
- Conditions
- Health Condition 1: null- Major Depressive Disorder
- Registration Number
- CTRI/2009/091/000129
- Lead Sponsor
- Emcure Pharmaceuticals Limited Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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.Timepoint: 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.Timepoint: 0,15,30,45,60 days