Major Depressive DisorderPhase 3NCT00811252

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

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

To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients. Read more about this study

Who is it for?: Ages 65 years and older
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: 453 participants
Where: No sites listed yet
Study dates: Jan 2009to Mar 2010
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
Reported duration of the current episode of at least 4 weeks
MADRS total score >=26
At least one previous MDE before the age of 60 years

Who cannot join

Mini Mental State Exam (MMSE) <24
Any current anxiety disorder as defined in the DSM-IV-TR
Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
Presence or history of a clinically significant neurological disorder (including epilepsy)
Neurodegenerative disorder (Alzheimer's disease, Parkinson disease, multiple sclerosis, Huntington disease, etc)

Show all 9Show fewer

Any Axis II disorder that might compromise the study
Significant risk of suicide according to the investigator's opinion, or has a score >=5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months
Other inclusion and exclusion criteria may apply.

About this study

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients

Conditions: Major Depressive Disorder
Being tested: Placebo, Vortioxetine (Lu AA21004), Duloxetine
Keywords: Depression, Elderly, Acute treatment
Medical subject headings: Depressive Disorder, Major, Depression

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
encapsulated tablets; daily; orally
DuloxetineDrug
Also called Cymbalta®
encapsulated tablets; daily; orally

Study groups in NCT00811252
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Vortioxetine 5 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 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

Secondary outcomes (12)

Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Measured: Baseline and Week 6
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Measured: Baseline and Week 4
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Measured: Baseline and Week 2
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
Measured: Baseline and Week 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.
Measured: Baseline and 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 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 GDS Total Score After 8 Weeks of Treatment
The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.
Measured: Baseline and Week 8
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Measured: Week 8
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Measured: Week 8
Risk of Suicidality Using C-SSRS Scores
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.
Measured: Up to 8 weeks

Timeline

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

Jan 2009Mar 2010

First posted18 Dec 2008 (estimated)
Study startJan 2009
Primary completionFeb 2010
Study completionMar 2010

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 (1)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: 453 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00811252
Sponsor's protocol ID: 12541A
Other IDs: 2008-002901-38, 2008
Status last verified: Dec 2013
First submitted: 17 Dec 2008
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457.
PubMed 22572889

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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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed Dose Study Comparing the Efficacy and Safety of [Vortioxetine] Lu AA21004 in Acute Treatment of Major Depressive Disorder in Elderly Patients
ClinicalTrials.gov ID: NCT00811252
Acronym / sponsor ID: 12541A
Conditions: Major Depressive Disorder
Keywords: Depression, Elderly, Acute treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 453 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Feb 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 18 Dec 2008 (estimated)
Results: Posted 18 Dec 2013

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: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Vortioxetine 5 mg	Experimental	Drug: Vortioxetine (Lu AA21004)
Duloxetine 60 mg	Other	Drug: DuloxetineActive reference

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
Reported duration of the current episode of at least 4 weeks
MADRS total score >=26
At least one previous MDE before the age of 60 years

Key exclusion criteria (9 listed)

Mini Mental State Exam (MMSE) <24
Any current anxiety disorder as defined in the DSM-IV-TR
Current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
Presence or history of a clinically significant neurological disorder (including epilepsy)

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: Brintellixencapsulated tablets; daily; orally	Drug	Vortioxetine 5 mg
DuloxetineAlso: Cymbalta®encapsulated tablets; daily; orally	Drug	Duloxetine 60 mg

Primary outcome

Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
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.

12 secondary outcomes

Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Time frame: Baseline and Week 6
Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Time frame: Baseline and Week 4
Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Time frame: Baseline and Week 2
Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
Time frame: Baseline and Week 1
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
Time frame: Baseline and 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 in Clinical Status Using CGI-I Score at Week 8
Time frame: Week 8
Change From Baseline in GDS Total Score After 8 Weeks of Treatment
Time frame: Baseline and Week 8
Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Time frame: Week 8
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 8
Risk of Suicidality Using C-SSRS Scores
Time frame: Up to 8 weeks

Results and safety

Results posted to the registry on 18 Dec 2013, 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	145	128
Vortioxetine 5 mg	156	136
Duloxetine 60 mg	151	128

Primary outcome: Change From Baseline in HAM-D-24 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 5 mg n = 155	Duloxetine 60 mg n = 148
Value	-10.3 (0.76)	-13.7 (0.74)	-15.8 (0.75)

Placebo vs Vortioxetine 5 mg: Mean Difference (Final Values): -3.32 (95% CI -5.31 to -1.34), p = 0.0011, ANCOVA
Placebo vs Duloxetine 60 mg: Mean Difference (Final Values): -5.48 (95% CI -7.50 to -3.46), p <0.0001, 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)

12 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	4 of 145 (2.8%)	63 of 145 (43.4%)	Not reported
Vortioxetine 5 mg	1 of 156 (0.6%)	72 of 156 (46.2%)	Not reported
Duloxetine 60 mg	1 of 151 (0.7%)	104 of 151 (68.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22572889Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457.

Related trials for Major Depressive Disorder

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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 4 inclusion and 9 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 29 Jan 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 18 Dec 2013). 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 HAM-D-24 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 NCT00811252, which also lists 1 linked publication.

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 29 Jan 2014.