Major Depressive DisorderPhase 3NCT00694304

Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

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

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment. 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?: No, everyone receives an active treatment
How many people: 535 participants
Where: No sites listed yet
Study dates: May 2008to Apr 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Who cannot join

Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication
Other protocol-defined inclusion and exclusion criteria may apply.

About this study

Official title: A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Being tested: Vortioxetine (Lu AA21004)
Keywords: Major Depressive Disorder, Long-term, Safety, Open-label
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.

Vortioxetine (Lu AA21004)Drug
Also called Brintellix
2.5, 5, or 10 mg/day; tablets; orally

Study groups in NCT00694304
Study group	Role	What they receive
Vortioxetine	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.

Number of Patients With Adverse Events (AEs)
Measured: Baseline to end of the 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Measured: Baseline to Week 52

Secondary outcomes (8)

Change From Baseline in MADRS Total Score After 52 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 52
Change From Baseline in HAM-D-24 Total Score After 52 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 52
Change From Baseline in HAM-A Total Score After 52 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 52
Change From Baseline in CGI-S Score After 52 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 52
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Measured: Week 52
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
Measured: Week 52
Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment
Measured: Baseline and Week 52
Change From Baseline in SDS Total Score After 52 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 52

Timeline

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

May 2008Apr 2010

First posted10 Jun 2008 (estimated)
Study startMay 2008
Primary completionMar 2010
Study completionApr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 535 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00694304
Sponsor's protocol ID: 11984B
Other IDs: EudraCT 2007-004992-21
Status last verified: Feb 2014
First submitted: 6 Jun 2008
Last updated: 1 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.
PubMed 22978748

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

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00694304
Acronym / sponsor ID: 11984B
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, Long-term, Safety, Open-label
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 535 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Mar 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 10 Jun 2008 (estimated)
Results: Posted 1 Apr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vortioxetine	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 (1 listed)

Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A

Key exclusion criteria (4 listed)

Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
Female patients of childbearing potential who are not using effective contraception
Use of any psychoactive medication
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
Vortioxetine (Lu AA21004)Also: Brintellix2.5, 5, or 10 mg/day; tablets; orally	Drug	Vortioxetine

Primary outcome

Number of Patients With Adverse Events (AEs)
Time frame: Baseline to end of the 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time frame: Baseline to Week 52

8 secondary outcomes

Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Change From Baseline in CGI-S Score After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Time frame: Week 52
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 52
Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Change From Baseline in SDS Total Score After 52 Weeks of Treatment
Time frame: Baseline and Week 52

Results and safety

Results posted to the registry on 1 Apr 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
Vortioxetine 2.5, 5, or 10 mg/Day	535	328

Primary outcome: Number of Patients With Adverse Events (AEs)

Time frame: Baseline to end of the 4-week safety follow-up period. Number. Unit: participants

Measure	Vortioxetine 2.5, 5, or 10 mg/Day n = 535
Patients With AEs	391
Patients With SAEs	18
Patients With AEs Leading to Withdrawal	42

Population analysed: APTS

Primary outcome: Percentage of Patients Who Withdrew Due to Intolerance to Treatment

Time frame: Baseline to Week 52. Number. Unit: percentage of patients

Measure	Vortioxetine 2.5, 5, or 10 mg/Day n = 535
Value	7.7

Population analysed: APTS

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vortioxetine 2.5, 5, or 10 mg/Day	18 of 535 (3.4%)	256 of 535 (47.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22978748Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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 1 inclusion and 4 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 1 Apr 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. 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 1 Apr 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?

Number of Patients With Adverse Events (AEs) (time frame: Baseline to end of the 4-week safety follow-up period). The study lists 2 primary outcomes in all. 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 NCT00694304, 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 1 Apr 2014.