Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
- Registration Number
- NCT04288895
- Lead Sponsor
- H. Lundbeck A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vortioxetine Vortioxetine flexible-dose
- Primary Outcome Measures
Name Time Method Number of participants with Treatment-Emergent Adverse Events From baseline to week 12
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (24)
Vinaya Hospital & Research Centre (IN1007)
🇮🇳Mangalore, Karnataka, India
BJ Medical College and Civil Hospital (IN028)
🇮🇳Ahmedabad, Gujarat, India
Mangala Hospital & Mangala Kidney Foundation (IN1006)
🇮🇳Mangalore, Karnataka, India
Shree Hatkesh Health Foundation (IN1016)
🇮🇳Junagadh, Gujarat, India
K. S. Hegde Medical Academy (IN1003)
🇮🇳Mangalore, Karnataka, India
Lata Mangeshkar Medical Foundation's (IN1001)
🇮🇳Pune, Maharashtra, India
Nagecha Hospital, Creative Chamber (IN1015)
🇮🇳Rajkot, Gujarat, India
Divyam Clinic (IN1025)
🇮🇳Surat, Gujarat, India
GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
🇮🇳Vadodara, Gujarat, India
Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
🇮🇳Mysuru, Karnataka, India
IQRAA International Hospital & Research Centre (IN030)
🇮🇳Kozhikode, Kerala, India
Arneja Heart and Multispeciality Hospital (IN1022)
🇮🇳Nagpur, Maharashtra, India
Central Institute of Behavioural Sciences (IN1019)
🇮🇳Nagpur, Maharashtra, India
ASHA hospital (IN1018)
🇮🇳Hyderabad, Telangana, India
Maharaja Agarsen Hospital (IN1021)
🇮🇳Delhi, India
Ratandeep Multispecialty Hospital (IN1002)
🇮🇳Ahmedabad, Gujarat, India
People Tree Hospitals (IN1027)
🇮🇳Bengaluru, Karnataka, India
Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
🇮🇳Aurangabad, Maharashtra, India
Oyster and Pearl Hospital (IN1014)
🇮🇳Pune, Maharashtra, India
Dayanand Medical College and Hospital (IN024)
🇮🇳Ludhiana, Punjab, India
Deva Institute of Healthcare and Research PVT ltd. (IN1005)
🇮🇳Varanasi, Uttar Pradesh, India
Chopda Medicare & Research Centre (IN023)
🇮🇳Nashik, Maharashtra, India
MITR Foundation 1 (IN1013)
🇮🇳Ahmedabad, Gujarat, India
Institute of Post Graduate Medical Education and Research (IN1026)
🇮🇳Kolkata, West Bengal, India