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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110026
    • Maharaja Agarsen Hospital (IN1021)
  • Gujarat
    • Ahmedabad, Gujarat, India, 380008
      • Ratandeep Multispecialty Hospital (IN1002)
    • Ahmedabad, Gujarat, India, 380013
      • MITR Foundation 1 (IN1013)
    • Ahmedabad, Gujarat, India, 380016
      • BJ Medical College and Civil Hospital (IN028)
    • Junagadh, Gujarat, India, 362001
      • Shree Hatkesh Health Foundation (IN1016)
    • Rajkot, Gujarat, India, 360001
      • Nagecha Hospital, Creative Chamber (IN1015)
    • Surat, Gujarat, India, 395001
      • Divyam Clinic (IN1025)
    • Vadodara, Gujarat, India, 390021
      • GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
  • Karnataka
    • Bengaluru, Karnataka, India, 560 022
      • People Tree Hospitals (IN1027)
    • Mangalore, Karnataka, India, 575 003
      • Vinaya Hospital & Research Centre (IN1007)
    • Mangalore, Karnataka, India, 575003
      • Mangala Hospital & Mangala Kidney Foundation (IN1006)
    • Mangalore, Karnataka, India, 575018
      • K. S. Hegde Medical Academy (IN1003)
    • Mysuru, Karnataka, India, 570001
      • Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
  • Kerala
    • Kozhikode, Kerala, India, 673009
      • IQRAA International Hospital & Research Centre (IN030)
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431005
      • Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
    • Nagpur, Maharashtra, India, 440010
      • Arneja Heart and Multispeciality Hospital (IN1022)
    • Nagpur, Maharashtra, India, 440010
      • Central Institute of Behavioural Sciences (IN1019)
    • Nashik, Maharashtra, India, 422005
      • Chopda Medicare & Research Centre (IN023)
    • Pune, Maharashtra, India, 411004
      • Lata Mangeshkar Medical Foundation's (IN1001)
    • Pune, Maharashtra, India, 411005
      • Oyster and Pearl Hospital (IN1014)
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Dayanand Medical College and Hospital (IN024)
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • ASHA hospital (IN1018)
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221005
      • Deva Institute of Healthcare and Research PVT ltd. (IN1005)
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Institute of Post Graduate Medical Education and Research (IN1026)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine; flexible-dose	Drug: Vortioxetine; 5 - 20 mg/day flexible-dose vortioxetine, tablets, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Treatment-Emergent Adverse Events	From baseline to week 12

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): March 12, 2022

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 17775A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No