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Clinical Trials/NCT01323478
NCT01323478CompletedPhase 3

A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder

H. Lundbeck A/S0 sites71 target enrollmentStarted: April 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
71
Primary Endpoint
Number of Patients With Adverse Events (AEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study

Exclusion Criteria

  • •Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)
  • •Female patients of childbearing potential who are not using effective contraception
  • •Use of any psychoactive medication
  • •The patient, in the investigator's clinical judgment, has a significant risk of suicide.
  • •Other protocol-defined inclusion and exclusion criteria applied.

Arms & Interventions

Vortioxetine

Experimental

Intervention: Vortioxetine (Lu AA21004) (Drug)

Outcomes

Primary Outcomes

Number of Patients With Adverse Events (AEs)

Time Frame: Baseline to end of the 4-week safety follow-up period

Percentage of Patients Who Withdrew Due to Intolerance to Treatment

Time Frame: Baseline to Week 52

Secondary Outcomes

  • Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)(Baseline from lead-in study 13267A (NCT01140906) and Week 52)
  • ASEX Total Score After 52 Weeks of Treatment(Week 52)
  • Risk of Suicidality Using C-SSRS Scores(Up to 52 weeks)
  • Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)(Baseline and Week 52)
  • Change From Baseline in MADRS Total Score After 52 Weeks of Treatment(Baseline and Week 52)
  • Change From Baseline in CGI-S Score After 52 Weeks of Treatment(Baseline and Week 52)
  • Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment(Baseline and Week 52)
  • SDS Total Score After 52 Weeks of Treatment(Week 52)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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