Clinical trial NCT04288895: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9) total score
timeFrame: From baseline to week 12
measure: Change in Clinical Global Impression-severity of illness (CGI-S) score
timeFrame: From baseline to week 12
measure: Clinical Global Impression-improvement (CGI-I)
timeFrame: At week 12
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Ratandeep Multispecialty Hospital (IN1002)
state: Gujarat
city: Ahmedabad
country: India
facility: MITR Foundation 1 (IN1013)
state: Gujarat
city: Ahmedabad
country: India
facility: BJ Medical College and Civil Hospital (IN028)
state: Gujarat
city: Junagadh
country: India
facility: Shree Hatkesh Health Foundation (IN1016)
state: Gujarat
city: Rajkot
country: India
facility: Nagecha Hospital, Creative Chamber (IN1015)
state: Gujarat
city: Surat
country: India
facility: Divyam Clinic (IN1025)
state: Gujarat
city: Vadodara
country: India
facility: GMERS Medical College and Hospital,Department of Psychiatry (IN1004)
state: Gujarat
city: Bengaluru
country: India
facility: People Tree Hospitals (IN1027)
state: Karnataka
city: Mangalore
country: India
facility: Vinaya Hospital & Research Centre (IN1007)
state: Karnataka
city: Mangalore
country: India
facility: Mangala Hospital & Mangala Kidney Foundation (IN1006)
state: Karnataka
city: Mangalore
country: India
facility: K. S. Hegde Medical Academy (IN1003)
state: Karnataka
city: Mysuru
country: India
facility: Department of Psychiatry K R Hospital Mysore Medical College and Research Institute (IN1020)
state: Karnataka
city: Kozhikode
country: India
facility: IQRAA International Hospital & Research Centre (IN030)
state: Kerala
city: Aurangabad
country: India
facility: Society for Psychiatric Update and Research, Shanti Nursing Home (IN1008)
state: Maharashtra
city: Nagpur
country: India
facility: Arneja Heart and Multispeciality Hospital (IN1022)
state: Maharashtra
city: Nagpur
country: India
facility: Central Institute of Behavioural Sciences (IN1019)
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare & Research Centre (IN023)
state: Maharashtra
city: Pune
country: India
facility: Lata Mangeshkar Medical Foundation's (IN1001)
state: Maharashtra
city: Pune
country: India
facility: Oyster and Pearl Hospital (IN1014)
state: Maharashtra
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital (IN024)
state: Punjab
city: Hyderabad
country: India
facility: ASHA hospital (IN1018)
state: Telangana
city: Varanasi
country: India
facility: Deva Institute of Healthcare and Research PVT ltd. (IN1005)
state: Uttar Pradesh
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research (IN1026)
state: West Bengal
city: Delhi
country: India
facility: Maharaja Agarsen Hospital (IN1021)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: