Health Condition 1: null- Patients with major depressive disorder
Conditions
Interventions
Intervention1: Levomilnacipran 20 mg, 40 mg, 80 mg and 120 mg ER Capsules: it will be initiated at 20 mg once daily for 2 days and then can be increased to 40 mg once daily on day 3 and on day 7 it ag
Sponsors
MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed patients with Major Depressive Disorder (MDD) 2. Outpatients (18-65 years) meeting DSM-IV criteria for a major depressive episode (duration � 1 month) 3. MDD patients with a 17-item Hamilton Depression Rating Scale (HDRS17) score > 22 and Sheehan Disability Scale (SDS) score � 10 4. Women of child bearing age willing to take contraceptive measure to prevent pregnancy during the study 5. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to the study drugs 2. Patients with suicidal ideation where study participation is deemed unsafe by the study clinician 3. Women who are pregnant or breastfeeding, or women of childbearing potential not using a medically accepted means of contraception 4. Serious or unstable medical illness such as liver disease, renal disease or Cardiovascular disease 5. Patient with history of narrow angle Glaucoma 6. Lifetime history of organic mental disorder, schizophrenia spectrum illness, bipolar disorder that would interfere with trial assessments 7. MDD with psychotic features, substance use disorder such as alcohol or nicotine active in the prior 12 months 8. Significant bleeding disorder 9. Patients with any alcohol or substance dependence in the past 6 months, major physical illness, significant ECG, hepatic or renal liver abnormalities 10. Patient having cardiac abnormalities as confirmed by ECG. 11. Current use of other psychotropic drugs other than antihistamines 12. History of drug abuse or alcohol abuse 13. Patients with investigational psychotropic drug use in the prior 3 months 14. Presence of any significant disease including immunodeficiency, hepatic, renal, cardiovascular, or hematologic disease or any other health condition that, in the opinion of the investigator, would preclude participation in the study. 15. Clinically significant renal (estimated glomerular filtration rate: 16. Patients taking concomitant medications with primarily central nervous system activity 17. Patients participating in any other clinical trial in the past 3 months. 18. Patients with obsessive compulsive disorder, with manic or hypomanic episode, schizophrenia or any other psychotic disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) HDRS17 response defined as ââ?°Â¥50% reduction in total HDRS17 score from base line and remission defined as total score ââ?°Â¤7 2) MADRS response defined as ââ?°Â¥50% reduction in total MADRS score from base line Timepoint: Visit 1 (Screening Visit), Visit 2 (Day 01),Visit 3 (Day 03), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hamilton Depression Rating Scale (HDRS17) scoreTimepoint: Visit 1 (Screening Visit), Visit 2 (Day 01, Randomization Visit),Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2);Changes in Clinical Global Impression - Severity scale (CGI-S) scaleTimepoint: Visit 1 (Screening Visit), Visit 2 (Day 01, Randomization Visit),Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2);Changes in Clinical Global Impressions - Improvement of Illness (CGI-I) scaleTimepoint: Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2);Changes in Sheehan Disability Scale (SDS)Timepoint: Visit 1 (Screening Visit), Visit 2 (Day 01, Randomization Visit),Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2);Mean changes in the MADRS scores from baselineTimepoint: Visit 1 (Screening Visit), Visit 2 (Day 01, Randomization Visit),Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2);Percentage of remission defined as MADRS total score ââ?°Â¤ 10Timepoint: Visit 1 (Screening Visit), Visit 2 (Day 01, Randomization Visit),Visit 3 (Day 03 Visit), Visit 4 (Day 7 Ã?± 2 days), Visit 5 (Day 14 Ã?± 2 days), Visit 6 (Day 28 Ã?± 2), Visit 7 (Day 56 Ã?± 2) and Visit 8 (Day 84 Ã?± 2) | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
Ocius Life Sciences Private Limited
Outcome results
None listed