Major Depressive DisorderPhase 2NCT00839423

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

A Phase 2 study testing Vortioxetine (Lu AA21004) and Venlafaxine XL 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

Search all trials

Trial summary

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Vortioxetine (Lu AA21004) and Venlafaxine XL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 426 participants
Where: No sites listed yet
Study dates: Aug 2006to Sep 2007
Phase: Phase 2
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 65 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)
Current MDE duration of at least 3 months and less than 12 months
The patient has a MADRS total score >=30

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: Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Placebo, Vortioxetine (Lu AA21004), Venlafaxine XL
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
encapsulated tablets, daily, orally
Venlafaxine XLDrug
Also called Effexor®
capsules, daily, orally

Study groups in NCT00839423
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Vortioxetine (Lu AA21004) 5 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)
Vortioxetine (Lu AA21004) 10 mg	Experimental	Not described Receives: Drug: Vortioxetine (Lu AA21004)
Venlafaxine XL 225 mg	Other	Active Reference Receives: Drug: Venlafaxine XL

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 6 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 6

Secondary outcomes (7)

Change From Baseline in MADRS Total Score After 1 Week of Treatment
Measured: Baseline and Week 1
Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
Measured: Baseline and Week 6
Change From Baseline in HAM-A Total Score After 6 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 6
Change From Baseline in CGI-S Score After 6 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 6
Change in Clinical Status Using CGI-I Score at Week 6
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 6
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Measured: Week 6
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
Measured: Week 6

Timeline

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

Aug 2006Sep 2007

First posted9 Feb 2009 (estimated)
Study startAug 2006
Primary completionAug 2007
Study completionSep 2007

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839423
Sponsor's protocol ID: 11492A
Other IDs: 2006-001515-29
Status last verified: Apr 2014
First submitted: 6 Feb 2009
Last updated: 13 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.
PubMed 21767441

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 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT00839423
Acronym / sponsor ID: 11492A
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, Placebo-controlled, Active reference, Multicenter study, Randomised study, Acute treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Aug 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 9 Feb 2009 (estimated)
Results: Posted 17 Dec 2013

Clinical summary

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

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Vortioxetine (Lu AA21004) 5 mg	Experimental	Drug: Vortioxetine (Lu AA21004)
Vortioxetine (Lu AA21004) 10 mg	Experimental	Drug: Vortioxetine (Lu AA21004)
Venlafaxine XL 225 mg	Other	Drug: Venlafaxine XLActive Reference

Who may qualify

Ages: 18 to 65 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)
Current MDE duration of at least 3 months and less than 12 months
The patient has a MADRS total score >=30

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: Brintellixencapsulated tablets, daily, orally	Drug	Vortioxetine (Lu AA21004) 10 mg, Vortioxetine (Lu AA21004) 5 mg
Venlafaxine XLAlso: Effexor®capsules, daily, orally	Drug	Venlafaxine XL 225 mg

Primary outcome

Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
Time frame: Baseline and Week 6
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.

7 secondary outcomes

Change From Baseline in MADRS Total Score After 1 Week of Treatment
Time frame: Baseline and Week 1
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-A Total Score After 6 Weeks of Treatment
Time frame: Baseline and Week 6
Change From Baseline in CGI-S Score After 6 Weeks of Treatment
Time frame: Baseline and Week 6
Change in Clinical Status Using CGI-I Score at Week 6
Time frame: Week 6
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Time frame: Week 6
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
Time frame: Week 6

Results and safety

Results posted to the registry on 17 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	105	87
Vortioxetine 5 mg	108	98
Vortioxetine 10 mg	100	82
Venlafaxine 225 mg	113	93

Primary outcome: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment

Time frame: Baseline and Week 6. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 105	Vortioxetine 5 mg n = 108	Vortioxetine 10 mg n = 100	Venlafaxine 225 mg n = 112
Value	-14.50 (1.03)	-20.40 (1.01)	-20.20 (1.04)	-20.92 (0.99)

Placebo vs Vortioxetine 10 mg: Mean Difference (Final Values): -5.70 (95% CI -8.49 to -2.91), p <0.0001, ANCOVA
Placebo vs Vortioxetine 5 mg: Mean Difference (Final Values): -5.90 (95% CI -8.64 to -3.17), p <0.0001, ANCOVA
Placebo vs Venlafaxine 225 mg: Mean Difference (Final Values): -6.42 (95% CI -9.13 to -3.72), 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 baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 105 (0%)	53 of 105 (50.5%)	Not reported
Vortioxetine 5 mg	0 of 108 (0%)	63 of 108 (58.3%)	Not reported
Vortioxetine 10 mg	2 of 100 (2%)	66 of 100 (66%)	Not reported
Venlafaxine 225 mg	1 of 113 (0.9%)	78 of 113 (69%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21767441Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.

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 2 study testing Vortioxetine (Lu AA21004) and Venlafaxine XL 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 13 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 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 MADRS Total Score After 6 Weeks of Treatment (time frame: Baseline and Week 6). 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 NCT00839423, 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 13 May 2014.