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

Last updated: March 17, 2022
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

4

Condition

Depression (Major/severe)

Depression

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT04288895
17775A
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient has a Major Depressive Episode (MDE), is diagnosed with Major DepressiveDisorder (MDD) according to DSM-5® and would benefit from pharmacological treatmentwith vortioxetine. The current MDE should be confirmed using the Mini InternationalNeuropsychiatric Interview (MINI).
  • The patient has a CGI-S ≥4 at screening.

Exclusion

Exclusion Criteria:

  • The patient has a significant risk of suicide according to investigator's clinicaljudgment or has made an actual suicide attempt in the period of 6 months prior toscreening.
  • The patient previously received vortioxetine. Other in- and exclusion criteria may apply.

Study Design

Total Participants: 400
Study Start date:
February 20, 2020
Estimated Completion Date:
March 12, 2022

Connect with a study center

  • BJ Medical College and Civil Hospital (IN028)

    Ahmedabad, Gujarat 380016
    India

    Site Not Available

  • MITR Foundation 1 (IN1013)

    Ahmedabad, Gujarat 380013
    India

    Site Not Available

  • Ratandeep Multispecialty Hospital (IN1002)

    Ahmedabad, Gujarat 380008
    India

    Site Not Available

  • Shree Hatkesh Health Foundation (IN1016)

    Junagadh, Gujarat 362001
    India

    Site Not Available

  • Nagecha Hospital, Creative Chamber (IN1015)

    Rajkot, Gujarat 360001
    India

    Site Not Available

  • Divyam Clinic (IN1025)

    Surat, Gujarat 395001
    India

    Site Not Available

  • GMERS Medical College and Hospital,Department of Psychiatry (IN1004)

    Vadodara, Gujarat 390021
    India

    Site Not Available

  • People Tree Hospitals (IN1027)

    Bengaluru, Karnataka 560 022
    India

    Site Not Available

  • K. S. Hegde Medical Academy (IN1003)

    Mangalore, Karnataka 575018
    India

    Site Not Available

  • Mangala Hospital & Mangala Kidney Foundation (IN1006)

    Mangalore, Karnataka 575003
    India

    Site Not Available

  • Vinaya Hospital & Research Centre (IN1007)

    Mangalore, Karnataka 575 003
    India

    Site Not Available

  • Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)

    Mysuru, Karnataka 570001
    India

    Site Not Available

  • IQRAA International Hospital & Research Centre (IN030)

    Kozhikode, Kerala 673009
    India

    Site Not Available

  • Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)

    Aurangabad, Maharashtra 431005
    India

    Site Not Available

  • Arneja Heart and Multispeciality Hospital (IN1022)

    Nagpur, Maharashtra 440010
    India

    Site Not Available

  • Central Institute of Behavioural Sciences (IN1019)

    Nagpur, Maharashtra 440010
    India

    Site Not Available

  • Chopda Medicare & Research Centre (IN023)

    Nashik, Maharashtra 422005
    India

    Site Not Available

  • Lata Mangeshkar Medical Foundation's (IN1001)

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Oyster and Pearl Hospital (IN1014)

    Pune, Maharashtra 411005
    India

    Site Not Available

  • Dayanand Medical College and Hospital (IN024)

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • ASHA hospital (IN1018)

    Hyderabad, Telangana 500034
    India

    Site Not Available

  • Deva Institute of Healthcare and Research PVT ltd. (IN1005)

    Varanasi, Uttar Pradesh 221005
    India

    Site Not Available

  • Institute of Post Graduate Medical Education and Research (IN1026)

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Maharaja Agarsen Hospital (IN1021)

    Delhi, 110026
    India

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.