Major Depressive DisorderPhase 3NCT00635219

Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

A Phase 3 study testing Vortioxetine (Lu AA21004) and Duloxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vortioxetine (Lu AA21004) and Duloxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 766 participants
Where: No sites listed yet
Study dates: Feb 2008to Apr 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Other protocol-defined inclusion and exclusion criteria may apply.

About this study

Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: Placebo, Vortioxetine (Lu AA21004), Duloxetine
Keywords: Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
capsules; daily; orally
Vortioxetine (Lu AA21004)Drug
Also called Brintellix
2.5 mg/day; encapsulated tablets; orally
Vortioxetine (Lu AA21004)Drug
Also called Brintellix
5 mg/day; encapsulated tablets; orally
Vortioxetine (Lu AA21004)Drug
Also called Brintellix
10 mg/day; encapsulated tablets; orally
DuloxetineDrug
Also called Cymbalta®
60 mg/day; encapsulated capsules; orally

Study groups in NCT00635219
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Vortioxetine: 2.5 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)
Vortioxetine: 5 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)
Vortioxetine: 10 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)
Duloxetine: 60 mg	Other	Active reference Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 8

Secondary outcomes (9)

Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Measured: Baseline and Week 8
Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Measured: Week 8
Change in Clinical Status Using CGI-I Score at Week 8
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
Measured: 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
Measured: Baseline and Week 8
Change From Baseline in SDS Total Score After 8 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Measured: Baseline and Week 8
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Measured: Week 8
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.
Measured: Baseline and Week 8
Change From Baseline in CGI-S Score After 8 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Measured: Baseline and Week 8
Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.
Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Apr 2009

First posted13 Mar 2008 (estimated)
Study startFeb 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 766 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00635219
Sponsor's protocol ID: 11984A
Other IDs: EudraCT 2007-001870-95
Status last verified: Dec 2013
First submitted: 3 Mar 2008
Last updated: 11 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22209361
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.
PubMed 32242018
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.
PubMed 31818787
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.
PubMed 31087825
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.
PubMed 27780334

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
ClinicalTrials.gov ID: NCT00635219
Acronym / sponsor ID: 11984A
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 766 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 13 Mar 2008 (estimated)
Results: Posted 11 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
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	Drug: DuloxetineActive reference

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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
Other protocol-defined inclusion and exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebocapsules; daily; orally	Drug	Placebo
Vortioxetine (Lu AA21004)Also: Brintellix2.5 mg/day; encapsulated tablets; orally	Drug	Vortioxetine: 2.5 mg
Vortioxetine (Lu AA21004)Also: Brintellix5 mg/day; encapsulated tablets; orally	Drug	Vortioxetine: 5 mg
Vortioxetine (Lu AA21004)Also: Brintellix10 mg/day; encapsulated tablets; orally	Drug	Vortioxetine: 10 mg
DuloxetineAlso: Cymbalta®60 mg/day; encapsulated capsules; orally	Drug	Duloxetine: 60 mg

Primary outcome

Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
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.

9 secondary outcomes

Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Time frame: Week 8
Change in Clinical Status Using CGI-I Score at Week 8
Time frame: 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
Time frame: Baseline and Week 8
Change From Baseline in SDS Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 8
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
Change From Baseline in CGI-S Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 11 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	148	123
Vortioxetine 2.5 mg	155	130
Vortioxetine 5 mg	157	122
Vortioxetine 10 mg	151	117
Duloxetine 60 mg	155	113

Primary outcome: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment

Time frame: Baseline and Week 8. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 145	Vortioxetine 2.5 mg n = 155	Vortioxetine 5 mg n = 155	Vortioxetine 10 mg n = 151	Duloxetine 60 mg n = 149
Value	-14.8 (0.82)	-16.2 (0.79)	-16.5 (0.80)	-16.3 (0.80)	-16.8 (0.81)

Placebo vs Vortioxetine 5 mg: Mean Difference (Final Values): -1.70 (95% CI -3.92 to 0.51), p = 0.1321, ANCOVA
Placebo vs Vortioxetine 10 mg: Mean Difference (Final Values): -1.50 (95% CI -3.73 to 0.72), p = 0.1847, ANCOVA
Placebo vs Vortioxetine 2.5 mg: Mean Difference (Final Values): -1.38 (95% CI -3.59 to 0.82), p = 0.2187, ANCOVA

Population analysed: Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: 8-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 8-week double-blind treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 148 (2%)	64 of 148 (43.2%)	Not reported
Vortioxetine 2.5 mg	1 of 155 (0.6%)	61 of 155 (39.4%)	Not reported
Vortioxetine 5 mg	3 of 157 (1.9%)	63 of 157 (40.1%)	Not reported
Vortioxetine 10 mg	2 of 151 (1.3%)	62 of 151 (41.1%)	Not reported
Duloxetine 60 mg	2 of 155 (1.3%)	93 of 155 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22209361Baldwin 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.
Derived from this study: PubMed 32242018Belzeaux 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.
Derived from this study: PubMed 31818787Christensen 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.
Derived from this study: PubMed 31087825Belzeaux 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.
Derived from this study: PubMed 27780334McIntyre 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Email contact via H. Lundbeck A/S study director

LundbeckClinicalTrials@lundbeck.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vortioxetine (Lu AA21004) and Duloxetine in people with Major Depressive Disorder, run by H. Lundbeck A/S.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in MADRS Total Score After 8 Weeks of Treatment (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00635219, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.