NCT00839423

Brief Summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2 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

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

December 17, 2013

Completed
Last Updated

May 13, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

February 6, 2009

Results QC Date

October 28, 2013

Last Update Submit

April 22, 2014

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderPlacebo-controlledActive referenceMulticenter studyRandomised studyAcute treatment

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in MADRS Total Score After 6 Weeks of Treatment

    The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.

    Baseline and Week 6

Secondary Outcomes (7)

  • Change From Baseline in MADRS Total Score After 1 Week of Treatment

    Baseline and Week 1

  • Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment

    Baseline and Week 6

  • Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment

    Baseline and Week 6

  • Change From Baseline in CGI-S Score After 6 Weeks of Treatment

    Baseline and Week 6

  • Change in Clinical Status Using CGI-I Score at Week 6

    Week 6

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Vortioxetine (Lu AA21004) 5 mg

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Vortioxetine (Lu AA21004) 10 mg

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Venlafaxine XL 225 mg

OTHER

Active Reference

Drug: Venlafaxine XL

Interventions

PlaceboDRUG

capsules, daily, orally

Placebo
Vortioxetine (Lu AA21004)DRUG

encapsulated tablets, daily, orally

Also known as: Brintellix
Vortioxetine (Lu AA21004) 10 mgVortioxetine (Lu AA21004) 5 mg
Venlafaxine XLDRUG

capsules, daily, orally

Also known as: Effexor®
Venlafaxine XL 225 mg

Eligibility Criteria

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

You may qualify if:

  • MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
  • Current MDE duration of at least 3 months and less than 12 months
  • The patient has a MADRS total score \>=30

You may not qualify if:

  • Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
  • Any substance disorder within the previous 6 months
  • Female patients of childbearing potential who are not using effective contraception
  • Use of any psychoactive medication 2 weeks prior to screening and during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.

    PMID: 21767441RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

VortioxetineVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Results Point of Contact

Title
H. Lundbeck A/S
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
+45 3630 1311

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

August 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

May 13, 2014

Results First Posted

December 17, 2013

Record last verified: 2014-04