Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vortioxetine flexible-dose |
Drug: Vortioxetine
5 - 20 mg/day flexible-dose vortioxetine, tablets, orally
|
Outcome Measures
Primary Outcome Measures
- Number of participants with Treatment-Emergent Adverse Events [From baseline to week 12]
Secondary Outcome Measures
- Change in Patient Health Questionnaire-9 (PHQ-9) total score [From baseline to week 12]
The PHQ-9 is a patient-rated scale designed to screen for and assess depression. The PHQ-9 consists of questions on each of the 9 DSM-5® criteria for depression asking if they have bothered the patient over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity.
- Change in Clinical Global Impression-severity of illness (CGI-S) score [From baseline to week 12]
The CGI was developed to provide global measures of the severity of a patient's clinical condition and improvement or worsening during clinical studies. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
- Clinical Global Impression-improvement (CGI-I) [At week 12]
The CGI was developed to provide global measures of the severity of a patient's clinical condition and improvement or worsening during clinical studies. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient has a Major Depressive Episode (MDE), is diagnosed with Major Depressive Disorder (MDD) according to DSM-5® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
-
The patient has a CGI-S ≥4 at screening.
Exclusion Criteria:
-
The patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening.
-
The patient previously received vortioxetine.
Other in- and exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ratandeep Multispecialty Hospital (IN1002) | Ahmedabad | Gujarat | India | 380008 |
| 2 | MITR Foundation 1 (IN1013) | Ahmedabad | Gujarat | India | 380013 |
| 3 | BJ Medical College and Civil Hospital (IN028) | Ahmedabad | Gujarat | India | 380016 |
| 4 | Shree Hatkesh Health Foundation (IN1016) | Junagadh | Gujarat | India | 362001 |
| 5 | Nagecha Hospital, Creative Chamber (IN1015) | Rajkot | Gujarat | India | 360001 |
| 6 | Divyam Clinic (IN1025) | Surat | Gujarat | India | 395001 |
| 7 | GMERS Medical College and Hospital,Department of Psychiatry (IN1004) | Vadodara | Gujarat | India | 390021 |
| 8 | People Tree Hospitals (IN1027) | Bengaluru | Karnataka | India | 560 022 |
| 9 | Vinaya Hospital & Research Centre (IN1007) | Mangalore | Karnataka | India | 575 003 |
| 10 | Mangala Hospital & Mangala Kidney Foundation (IN1006) | Mangalore | Karnataka | India | 575003 |
| 11 | K. S. Hegde Medical Academy (IN1003) | Mangalore | Karnataka | India | 575018 |
| 12 | Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020) | Mysuru | Karnataka | India | 570001 |
| 13 | IQRAA International Hospital & Research Centre (IN030) | Kozhikode | Kerala | India | 673009 |
| 14 | Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008) | Aurangabad | Maharashtra | India | 431005 |
| 15 | Arneja Heart and Multispeciality Hospital (IN1022) | Nagpur | Maharashtra | India | 440010 |
| 16 | Central Institute of Behavioural Sciences (IN1019) | Nagpur | Maharashtra | India | 440010 |
| 17 | Chopda Medicare & Research Centre (IN023) | Nashik | Maharashtra | India | 422005 |
| 18 | Lata Mangeshkar Medical Foundation's (IN1001) | Pune | Maharashtra | India | 411004 |
| 19 | Oyster and Pearl Hospital (IN1014) | Pune | Maharashtra | India | 411005 |
| 20 | Dayanand Medical College and Hospital (IN024) | Ludhiana | Punjab | India | 141001 |
| 21 | ASHA hospital (IN1018) | Hyderabad | Telangana | India | 500034 |
| 22 | Deva Institute of Healthcare and Research PVT ltd. (IN1005) | Varanasi | Uttar Pradesh | India | 221005 |
| 23 | Institute of Post Graduate Medical Education and Research (IN1026) | Kolkata | West Bengal | India | 700020 |
| 24 | Maharaja Agarsen Hospital (IN1021) | Delhi | India | 110026 |
Sponsors and Collaborators
- H. Lundbeck A/S
Investigators
- Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17775A