Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India

Major Depressive Disorder Clinical Trial

Official title:

Open-label, Flexible-dose Study of Vortioxetine in Patients With Major Depressive Disorder in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288895
• Other study ID #: 17775A
• Status: Completed
• Phase: Phase 4
• Start date: February 20, 2020
• Est. completion date: March 12, 2022

Study information

• Verified date: March 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 12, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine
5 - 20 mg/day flexible-dose vortioxetine, tablets, orally

Locations

Country	Name	City	State
India	BJ Medical College and Civil Hospital (IN028)	Ahmedabad	Gujarat
India	MITR Foundation 1 (IN1013)	Ahmedabad	Gujarat
India	Ratandeep Multispecialty Hospital (IN1002)	Ahmedabad	Gujarat
India	Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)	Aurangabad	Maharashtra
India	People Tree Hospitals (IN1027)	Bengaluru	Karnataka
India	Maharaja Agarsen Hospital (IN1021)	Delhi
India	ASHA hospital (IN1018)	Hyderabad	Telangana
India	Shree Hatkesh Health Foundation (IN1016)	Junagadh	Gujarat
India	Institute of Post Graduate Medical Education and Research (IN1026)	Kolkata	West Bengal
India	IQRAA International Hospital & Research Centre (IN030)	Kozhikode	Kerala
India	Dayanand Medical College and Hospital (IN024)	Ludhiana	Punjab
India	K. S. Hegde Medical Academy (IN1003)	Mangalore	Karnataka
India	Mangala Hospital & Mangala Kidney Foundation (IN1006)	Mangalore	Karnataka
India	Vinaya Hospital & Research Centre (IN1007)	Mangalore	Karnataka
India	Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)	Mysuru	Karnataka
India	Arneja Heart and Multispeciality Hospital (IN1022)	Nagpur	Maharashtra
India	Central Institute of Behavioural Sciences (IN1019)	Nagpur	Maharashtra
India	Chopda Medicare & Research Centre (IN023)	Nashik	Maharashtra
India	Lata Mangeshkar Medical Foundation's (IN1001)	Pune	Maharashtra
India	Oyster and Pearl Hospital (IN1014)	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	Deva Institute of Healthcare and Research PVT ltd. (IN1005)	Varanasi	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment-Emergent Adverse Events		From baseline to week 12
Secondary	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.	From baseline to week 12
Secondary	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
Secondary	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