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Completed

NCT Number: NCT04288895

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BJ Medical College and Civil Hospital (IN028), Ahmedabad, Gujarat, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vortioxetine

Drug

5 - 20 mg/day flexible-dose vortioxetine, tablets, orally

Primary outcomes

  1. Number of participants with Treatment-Emergent Adverse Events

    Time frame: From baseline to week 12

Secondary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9) total score

    Time frame: 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.

  2. Change in Clinical Global Impression-severity of illness (CGI-S) score

    Time frame: 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).

  3. Clinical Global Impression-improvement (CGI-I)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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