Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04288895
NCT04288895
Completed
Phase 4

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

H. Lundbeck A/S24 sites in 1 country400 target enrollmentFebruary 20, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMajor Depressive Disorder
InterventionsVortioxetine
DrugsVortioxetine

Overview

Phase
Phase 4
Intervention
Vortioxetine
Conditions
Major Depressive Disorder
Sponsor
H. Lundbeck A/S
Enrollment
400
Locations
24
Primary Endpoint
Number of participants with Treatment-Emergent Adverse Events
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
February 20, 2020
End Date
March 12, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Vortioxetine

flexible-dose

Intervention: Vortioxetine

Outcomes

Primary Outcomes

Number of participants with Treatment-Emergent Adverse Events

Time Frame: From baseline to week 12

Secondary Outcomes

  • Change in Patient Health Questionnaire-9 (PHQ-9) total score(From baseline to week 12)
  • Change in Clinical Global Impression-severity of illness (CGI-S) score(From baseline to week 12)
  • Clinical Global Impression-improvement (CGI-I)(At week 12)

Study Sites (24)

Loading locations...

Similar Trials

Completed
Phase 3
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsMajor Depressive Disorder
NCT01323478H. Lundbeck A/S71
Completed
Phase 3
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsMajor Depressive Disorder
NCT00694304H. Lundbeck A/S535
Completed
Phase 3
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive DisorderMajor Depressive Disorder
NCT00707980Takeda836
Completed
Phase 4
A 10-Week, Open-Label, Flexible Dose Adaptive Study Evaluating the Efficacy of Vortioxetine in Subjects With Panic DisorderPanic Disorder
NCT02395510Siyan Clinical Corporation27
Completed
Phase 2
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in AdultsMajor Depressive Disorder
NCT00761306H. Lundbeck A/S74