NCT01571453

Brief Summary

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 13, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

March 28, 2012

Results QC Date

October 6, 2014

Last Update Submit

October 6, 2014

Conditions

Major Depressive Disorder

Keywords

MDD

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in MADRS Total Score at Week 8

    Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

    Baseline and Week 8

Secondary Outcomes (6)

  • Change in CGI-S Score From Baseline to Week 8

    Baseline and Week 8

  • CGI-I Score at Week 8

    Week 8

  • Change in HAM-A Total Score From Baseline to Week 8

    Baseline and Week 8

  • MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)

    Week 8

  • Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)

    Week 8

  • +1 more secondary outcomes

Study Arms (2)

Vortioxetine (Lu AA21004)

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Venlafaxine extended release

ACTIVE COMPARATOR
Drug: Venlafaxine extended release

Interventions

Vortioxetine (Lu AA21004)DRUG

10 mg/day

Also known as: Brintellix
Vortioxetine (Lu AA21004)
Venlafaxine extended releaseDRUG

150 mg/day

Also known as: Efexor® XL
Venlafaxine extended release

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
  • The patient has a MADRS total score ≥26
  • The patient has a CGI-S score ≥4
  • The reported duration of the current MDE is ≥3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wang G, Zhao K, Reynaud-Mougin C, Loft H, Ren H, Eriksen HF, Ettrup A. Successfully treated patients with vortioxetine versus venlafaxine: a simplified cost-effectiveness analysis based on a head-to-head study in Asian patients with major depressive disorder. Curr Med Res Opin. 2020 May;36(5):875-882. doi: 10.1080/03007995.2020.1723072. Epub 2020 Feb 13.

    PMID: 31990207DERIVED

  • Wang G, Gislum M, Filippov G, Montgomery S. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study. Curr Med Res Opin. 2015 Apr;31(4):785-94. doi: 10.1185/03007995.2015.1014028. Epub 2015 Feb 19.

    PMID: 25650503DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Email contact via H. Lundbeck A/S
Organization
Study Director
LundbeckClinicalTrials@lundbeck.com

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

April 5, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2013

Last Updated

October 13, 2014

Results First Posted

October 13, 2014

Record last verified: 2014-10