Major Depressive DisorderPhase 3NCT00596817

Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

A Phase 3 study testing Vortioxetine (Lu AA21004) 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.

Trial summary

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine. 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)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 639 participants
Where: No sites listed yet
Study dates: Dec 2007to Oct 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

Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
At least one other MDE before the current one
Moderate to severe depression

Who cannot join

Any current psychiatric disorder other than Major Depressive Disorder (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
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
Other protocol-defined inclusion and exclusion criteria may apply.

About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

Conditions: Major Depressive Disorder
Being tested: Placebo, Vortioxetine (Lu AA21004)
Keywords: Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study
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
encapsulated tablets, daily, orally

Study groups in NCT00596817
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Vortioxetine: 5 or 10 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)

What is being measured

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

Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
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: Within first 24 weeks of the double-blind period

Secondary outcomes (8)

Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
Measured: Within 64 weeks of the double-blind period
Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
Measured: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe.
Measured: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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: Double-blind Baseline and Week 24 of the double-blind period
Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
Measured: Week 24 of the double-blind period (Counted From Open-label Baseline)
Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
Measured: Week 24 of the double-blind period
Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
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: Week 24 of the double-blind period (Counted From Double-blind Baseline)

Timeline

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

Dec 2007Oct 2009

First posted17 Jan 2008 (estimated)
Study startDec 2007
Primary completionSep 2009
Study completionOct 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 (3)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: 639 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00596817
Sponsor's protocol ID: 11985A
Other IDs: 2007-001871-13
Status last verified: Feb 2014
First submitted: 8 Jan 2008
Last updated: 31 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9.
PubMed 22495621
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
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 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00596817
Acronym / sponsor ID: 11985A
Conditions: Major Depressive Disorder
Keywords: Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 639 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Sep 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 17 Jan 2008 (estimated)
Results: Posted 31 Mar 2014

Clinical summary

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

This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Vortioxetine: 5 or 10 mg	Experimental	Drug: Vortioxetine (Lu AA21004)

Who may qualify

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

Key inclusion criteria (3 listed)

Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
At least one other MDE before the current one
Moderate to severe depression

Key exclusion criteria (6 listed)

Any current psychiatric disorder other than Major Depressive Disorder (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
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12

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 or 10 mg

Primary outcome

Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
Time frame: Within first 24 weeks of the double-blind period
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.

8 secondary outcomes

Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
Time frame: Within 64 weeks of the double-blind period
Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
Time frame: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
Time frame: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment
Time frame: Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment
Time frame: Double-blind Baseline and Week 24 of the double-blind period
Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
Time frame: Week 24 of the double-blind period (Counted From Open-label Baseline)
Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 24 of the double-blind period
Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
Time frame: Week 24 of the double-blind period (Counted From Double-blind Baseline)

Results and safety

Results posted to the registry on 31 Mar 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	0	0
Vortioxetine: 5 or 10 mg	639	492

Primary outcome: Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator

Time frame: Within first 24 weeks of the double-blind period. Number. Unit: percentage of patients who relapsed

Measure	Placebo n = 192	Vortioxetine: 5 or 10 mg n = 204
Value	26.0	13.2

Placebo vs Vortioxetine: 5 or 10 mg: Hazard Ratio (HR): 2.01 (95% CI 1.26 to 3.21), p = 0.0035, Cox-model

Population analysed: FAS

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: 12-week open-label period, 24-week double-blind period and 4-week safety follow-up period. Other Adverse Events: 12-week open-label period and 24-week double-blind period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label Period (APTS)	14 of 639 (2.2%)	337 of 639 (52.7%)	Not reported
Placebo - Double-blind Period (FAS)	6 of 192 (3.1%)	73 of 192 (38%)	Not reported
Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)	7 of 204 (3.4%)	79 of 204 (38.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22495621Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9.
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 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) 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 6 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 31 Mar 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 31 Mar 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?

Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator (time frame: Within first 24 weeks of the double-blind period). 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 NCT00596817, which also lists 3 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 31 Mar 2014.