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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental | flexible-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | 5 - 20 mg/day flexible-dose vortioxetine, tablets, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) total score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other in- and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ratandeep Multispecialty Hospital (IN1002) | Ahmedabad | Gujarat | 380008 | India | ||
| MITR Foundation 1 (IN1013) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39110846 | Derived | Adair M, Bose R, Schmidt SN. Safety and effectiveness of vortioxetine in patients with major depressive disorder in a real-life clinical setting in India: results from an interventional, flexible-dose study. Curr Med Res Opin. 2024 Sep;40(9):1637-1645. doi: 10.1080/03007995.2024.2382773. Epub 2024 Aug 7. |
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| From baseline to week 12 |
| Change in Clinical Global Impression-severity of illness (CGI-S) score | 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). | From baseline to week 12 |
| Clinical Global Impression-improvement (CGI-I) | 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). | At week 12 |
| Ahmedabad |
| Gujarat |
| 380013 |
| India |
| BJ Medical College and Civil Hospital (IN028) | Ahmedabad | Gujarat | 380016 | India |
| Shree Hatkesh Health Foundation (IN1016) | Jūnāgadh | Gujarat | 362001 | India |
| Nagecha Hospital, Creative Chamber (IN1015) | Rajkot | Gujarat | 360001 | India |
| Divyam Clinic (IN1025) | Surat | Gujarat | 395001 | India |
| GMERS Medical College and Hospital,Department of Psychiatry (IN1004) | Vadodara | Gujarat | 390021 | India |
| People Tree Hospitals (IN1027) | Bengaluru | Karnataka | 560 022 | India |
| Vinaya Hospital & Research Centre (IN1007) | Mangalore | Karnataka | 575 003 | India |
| Mangala Hospital & Mangala Kidney Foundation (IN1006) | Mangalore | Karnataka | 575003 | India |
| K. S. Hegde Medical Academy (IN1003) | Mangalore | Karnataka | 575018 | India |
| Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020) | Mysuru | Karnataka | 570001 | India |
| IQRAA International Hospital & Research Centre (IN030) | Kozhikode | Kerala | 673009 | India |
| Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008) | Aurangabad | Maharashtra | 431005 | India |
| Arneja Heart and Multispeciality Hospital (IN1022) | Nagpur | Maharashtra | 440010 | India |
| Central Institute of Behavioural Sciences (IN1019) | Nagpur | Maharashtra | 440010 | India |
| Chopda Medicare & Research Centre (IN023) | Nashik | Maharashtra | 422005 | India |
| Lata Mangeshkar Medical Foundation's (IN1001) | Pune | Maharashtra | 411004 | India |
| Oyster and Pearl Hospital (IN1014) | Pune | Maharashtra | 411005 | India |
| Dayanand Medical College and Hospital (IN024) | Ludhiana | Punjab | 141001 | India |
| ASHA hospital (IN1018) | Hyderabad | Telangana | 500034 | India |
| Deva Institute of Healthcare and Research PVT ltd. (IN1005) | Varanasi | Uttar Pradesh | 221005 | India |
| Institute of Post Graduate Medical Education and Research (IN1026) | Kolkata | West Bengal | 700020 | India |
| Maharaja Agarsen Hospital (IN1021) | Delhi | 110026 | India |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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