Major Depression DisorderPhase 3NCT02400346
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
A Phase 3 study testing Adjunct brexpiprazole and ADT in people with Major Depression Disorder, run by H. Lundbeck A/S at 34 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Depression Disorder
- What is being tested?
- Adjunct brexpiprazole and ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 34 sitesin 5 countries
- Study dates
- Mar 2015to Jun 2016
- 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
Main Inclusion Criteria:
- • The patient is a man or woman aged ≥65 yrs
- The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).
- The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE).
- The patient has had the current MDE for ≥8 weeks
- The patient is currently treated with a protocol specified ADT for at least 6 weeks
- The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
- Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline
- Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline
Main Exclusion Criteria:
- • The patient has a clinically significant unstable illness
- The patient has newly diagnosed or unstable diabetes
- The patient has a Mini Mental State Exam (MMSE) score <24
- The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening.
- The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide
Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
34 sites in 5 countries.
34 sites in 5 countries
United States13 sites
US009
Allentown, Pennsylvania
US012
Arcadia, California
US001
Memphis, Tennessee
US004
Miami, Florida
US005
New York, New York
US008
New York, New York
US002
O'Fallon, Missouri
US014
Oklahoma City, Oklahoma
US007
Orlando, Florida
US011
San Antonio, Texas
US006
Smyrna, Georgia
US003
Staten Island, New York
US010
Toms River, New Jersey
Germany7 sites
DE002
Berlin
DE008
Berlin
DE003
Frankfurt
DE007
Hanover
DE006
Mittweida
DE001
Schwerin
DE005
Wiesbaden
Poland6 sites
PL006
Bialystok
PL003
Bydgoszcz
PL001
Chełmno
PL005
Gdansk
PL004
Lublin
PL002
Pruszcz Gdański
About this study
Official title: Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment
- Conditions
- Major Depression Disorder
- Being tested
- Adjunct brexpiprazole, ADT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunct brexpiprazoleDrug
Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.
ADTDrug
Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
| Study group | Role | What they receive |
|---|---|---|
| Adjunct brexpiprazole | Experimental | All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition Receives: Drug: Adjunct brexpiprazole; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment-Emergent Adverse Events
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Measured: Baseline to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Depression 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400346
- Sponsor's protocol ID
- 16160A
- Other IDs
- 2014-003547-35, 2014
- Status last verified
- Jul 2017
- First submitted
- 17 Mar 2015
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lepola U, Hefting N, Zhang D, Hobart M. Adjunctive brexpiprazole for elderly patients with major depressive disorder: An open-label, long-term safety and tolerability study. Int J Geriatr Psychiatry. 2018 Oct;33(10):1403-1410. doi: 10.1002/gps.4952. Epub 2018 Jul 23.
PubMed 30039634
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT02400346
- Acronym / sponsor ID
- 16160A
- Conditions
- Major Depression Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 26 Jun 2017
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 study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjunct brexpiprazole | Experimental | Drug: Adjunct brexpiprazole, Drug: ADTAll patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Adjunct brexpiprazoleWeeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily. Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg. | Drug | Adjunct brexpiprazole |
| ADTCitalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label | Drug | Adjunct brexpiprazole |
Primary outcome
Number of Patients With Treatment-Emergent Adverse Events
Time frame: Baseline to 30 weeks
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30039634Lepola U, Hefting N, Zhang D, Hobart M. Adjunctive brexpiprazole for elderly patients with major depressive disorder: An open-label, long-term safety and tolerability study. Int J Geriatr Psychiatry. 2018 Oct;33(10):1403-1410. doi: 10.1002/gps.4952. Epub 2018 Jul 23.
Related trials for Major Depression 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
34 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjunct brexpiprazole and ADT in people with Major Depression Disorder, run by H. Lundbeck A/S at 34 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Germany, Poland, Estonia, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 26 Jun 2017). 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 Treatment-Emergent Adverse Events (time frame: Baseline to 30 weeks). 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 NCT02400346, 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 10 Aug 2017.