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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Vortioxetine
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ratandeep Multispecialty Hospital (IN1002)
  • MITR Foundation 1 (IN1013)
  • BJ Medical College and Civil Hospital (IN028)
  • Shree Hatkesh Health Foundation (IN1016)
  • Nagecha Hospital, Creative Chamber (IN1015)
  • Divyam Clinic (IN1025)
  • GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
  • People Tree Hospitals (IN1027)
  • Vinaya Hospital & Research Centre (IN1007)
  • Mangala Hospital & Mangala Kidney Foundation (IN1006)
  • K. S. Hegde Medical Academy (IN1003)
  • Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
  • IQRAA International Hospital & Research Centre (IN030)
  • Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
  • Arneja Heart and Multispeciality Hospital (IN1022)
  • Central Institute of Behavioural Sciences (IN1019)
  • Chopda Medicare & Research Centre (IN023)
  • Lata Mangeshkar Medical Foundation's (IN1001)
  • Oyster and Pearl Hospital (IN1014)
  • Dayanand Medical College and Hospital (IN024)
  • ASHA hospital (IN1018)
  • Deva Institute of Healthcare and Research PVT ltd. (IN1005)
  • Institute of Post Graduate Medical Education and Research (IN1026)
  • Maharaja Agarsen Hospital (IN1021)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vortioxetine

Arm Description

flexible-dose

Outcomes

Primary Outcome Measures

Number of participants with Treatment-Emergent Adverse Events

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
February 26, 2020
Last Updated
March 17, 2022
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04288895
Brief Title
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India
Official Title
Open-label, Flexible-dose Study of Vortioxetine in Patients With Major Depressive Disorder in India
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
flexible-dose
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
5 - 20 mg/day flexible-dose vortioxetine, tablets, orally
Primary Outcome Measure Information:
Title
Number of participants with Treatment-Emergent Adverse Events
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9) total score
Description
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.
Time Frame
From baseline to week 12
Title
Change in Clinical Global Impression-severity of illness (CGI-S) score
Description
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).
Time Frame
From baseline to week 12
Title
Clinical Global Impression-improvement (CGI-I)
Description
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).
Time Frame
At week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Ratandeep Multispecialty Hospital (IN1002)
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380008
Country
India
Facility Name
MITR Foundation 1 (IN1013)
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Facility Name
BJ Medical College and Civil Hospital (IN028)
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Shree Hatkesh Health Foundation (IN1016)
City
Junagadh
State/Province
Gujarat
ZIP/Postal Code
362001
Country
India
Facility Name
Nagecha Hospital, Creative Chamber (IN1015)
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360001
Country
India
Facility Name
Divyam Clinic (IN1025)
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395001
Country
India
Facility Name
GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Facility Name
People Tree Hospitals (IN1027)
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560 022
Country
India
Facility Name
Vinaya Hospital & Research Centre (IN1007)
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575 003
Country
India
Facility Name
Mangala Hospital & Mangala Kidney Foundation (IN1006)
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
K. S. Hegde Medical Academy (IN1003)
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Facility Name
Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
IQRAA International Hospital & Research Centre (IN030)
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673009
Country
India
Facility Name
Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Arneja Heart and Multispeciality Hospital (IN1022)
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Central Institute of Behavioural Sciences (IN1019)
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Chopda Medicare & Research Centre (IN023)
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
Lata Mangeshkar Medical Foundation's (IN1001)
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Oyster and Pearl Hospital (IN1014)
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
Dayanand Medical College and Hospital (IN024)
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
ASHA hospital (IN1018)
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Deva Institute of Healthcare and Research PVT ltd. (IN1005)
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Facility Name
Institute of Post Graduate Medical Education and Research (IN1026)
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Maharaja Agarsen Hospital (IN1021)
City
Delhi
ZIP/Postal Code
110026
Country
India

12. IPD Sharing Statement

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

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