NCT00635219

Brief Summary

The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the 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
766

participants targeted

Target at P75+ for phase_3 major-depressive-disorder

Timeline
Completed

Started Feb 2008

Shorter than P25 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

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

February 11, 2014

Completed
Last Updated

February 11, 2014

Status Verified

December 1, 2013

Enrollment Period

1.2 years

First QC Date

March 3, 2008

Results QC Date

October 28, 2013

Last Update Submit

December 23, 2013

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 8 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 8

Secondary Outcomes (9)

  • Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment

    Baseline and Week 8

  • Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)

    Week 8

  • Change in Clinical Status Using CGI-I Score at Week 8

    Week 8

  • Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20

    Baseline and Week 8

  • Change From Baseline in SDS Total Score After 8 Weeks of Treatment

    Baseline and Week 8

  • +4 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Vortioxetine: 2.5 mg

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 5 mg

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Vortioxetine: 10 mg

EXPERIMENTAL
Drug: Vortioxetine (Lu AA21004)

Duloxetine: 60 mg

OTHER

Active reference

Drug: Duloxetine

Interventions

PlaceboDRUG

capsules; daily; orally

Placebo
Vortioxetine (Lu AA21004)DRUG

2.5 mg/day; encapsulated tablets; orally

Also known as: Brintellix
Vortioxetine: 2.5 mg
DuloxetineDRUG

60 mg/day; encapsulated capsules; orally

Also known as: Cymbalta®
Duloxetine: 60 mg

Eligibility Criteria

Age18 Years - 75 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)
  • Moderate to severe depression
  • Current MDE duration of at least 3 months

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 (5)

  • Baldwin DS, Loft H, Dragheim M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol. 2012 Jul;22(7):482-91. doi: 10.1016/j.euroneuro.2011.11.008. Epub 2011 Dec 30.

    PMID: 22209361RESULT

  • Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

    PMID: 32242018DERIVED

  • Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.

    PMID: 31818787DERIVED

  • Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556.

    PMID: 31087825DERIVED

  • McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.

    PMID: 27780334DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

VortioxetineDuloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiophenesSulfur CompoundsOrganic Chemicals

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 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 3, 2008

First Posted

March 13, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 11, 2014

Results First Posted

February 11, 2014

Record last verified: 2013-12