Major Depressive DisorderPhase 3NCT01837797

Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

A Phase 3 study testing Brexpiprazole 1 mg and Brexpiprazole 3 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD) 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?: Brexpiprazole 1 mg and Brexpiprazole 3 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 2 sitesUnited States
Study dates: Apr 2013to May 2014
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

The patient is an outpatient consulting a psychiatrist.
The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
The patient had at least one previous MDE before the age of 60 years.
The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.
The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential.

Who cannot join

The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
The patient, in the opinion of the investigator, or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
The patient has had neuroleptic malignant syndrome.

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The patient has any relevant medical history or current presence of systemic disease.
The patient has a neurodegenerative disorder.
The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

US001
National City, California, 91950
US008
Orlando, Florida, 32806

Other trials in United States

About this study

Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the Efficacy and Safety of Brexpiprazole (1 and 3 mg/Day) as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

Conditions: Major Depressive Disorder
Being tested: Placebo, Brexpiprazole 1 mg, Brexpiprazole 3 mg
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
Once daily, tablets, orally
Brexpiprazole 1 mgDrug
once daily dose, tablets, orally
Brexpiprazole 3 mgDrug
once daily dose, tablets, orally

Study groups in NCT01837797
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) Receives: Drug: Placebo
Brexpiprazole 1 mg	Experimental	Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day. Receives: Drug: Brexpiprazole 1 mg
Brexpiprazole 3 mg	Experimental	Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day. Receives: Drug: Brexpiprazole 3 mg

What is being measured

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

Change From Randomisation in Depressive Symptoms During the Randomised Treatment
Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Measured: From randomisation to end of treatment (week 20)

Secondary outcomes (9)

Number of Adverse Events
15 patients were enrolled to Period 2; only 3 patients completed due to study termination
Measured: From randomisation to follow-up (week 24)
Change From Randomisation in Clinical Global Impression During the Randomised Treatment
Clinical Global Impression - Severity of illness (CGI-S) score
Measured: From randomisation to end of treatment (week 20)
Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment
Sheehan Disability Scale (SDS) total score
Measured: From randomisation to end of treatment (week 20)
Change From Randomisation in Social Adaptation During the Randomised Treatment
Social Adaptation Self-evaluation Scale (SASS) total score
Measured: From randomisation to end of treatment (week 20)
Response During the Randomised Treatment
Based on a pre-specified decrease in MADRS total score
Measured: From randomisation to end of treatment (week 20)
Sustained Response During the Randomised Treatment
Based on a pre-specified decrease in MADRS total score
Measured: From randomisation to end of treatment (week 20)
Remission During the Randomised Treatment
Based on a pre-specified MADRS total score
Measured: From randomisation to end of treatment (week 20)
Sustained Remission During the Randomised Treatment
Based on a pre-specified MADRS total score
Measured: From randomisation to end of treatment (week 20)
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.
Measured: From randomisation to end of treatment (week 20)

Timeline

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

Apr 2013May 2014

First posted23 Apr 2013 (estimated)
Study startApr 2013
Primary completionMay 2014
Study completionMay 2014

Why it stopped: The study was terminated because of recruitment challenges

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.
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: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01837797
Sponsor's protocol ID: 14571A
Other IDs: 2012-001361-32
Status last verified: Sep 2018
First submitted: 4 Apr 2013
Last updated: 17 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the Efficacy and Safety of Brexpiprazole (1 and 3 mg/Day) as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
ClinicalTrials.gov ID: NCT01837797
Acronym / sponsor ID: 14571A
Conditions: Major Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because of recruitment challenges
Enrolment: 129 participants (actual)
Lead sponsor: H. Lundbeck A/SIndustry (pharma, biotech, devices)
Collaborators: Otsuka Pharmaceutical Co., Ltd.
Study start: Apr 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 23 Apr 2013 (estimated)
Results: Posted 3 Mar 2016

Clinical summary

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

To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

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: PlaceboPlacebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole 1 mg	Experimental	Drug: Brexpiprazole 1 mgBrexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day.
Brexpiprazole 3 mg	Experimental	Drug: Brexpiprazole 3 mgBrexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day.

Who may qualify

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

Key inclusion criteria (6 listed)

The patient is an outpatient consulting a psychiatrist.
The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
The patient had at least one previous MDE before the age of 60 years.
The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.

Key exclusion criteria (12 listed)

The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
The patient, in the opinion of the investigator, or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.

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
PlaceboOnce daily, tablets, orally	Drug	Placebo
Brexpiprazole 1 mgonce daily dose, tablets, orally	Drug	Brexpiprazole 1 mg
Brexpiprazole 3 mgonce daily dose, tablets, orally	Drug	Brexpiprazole 3 mg

Primary outcome

Change From Randomisation in Depressive Symptoms During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Montgomery and Aasberg Depression Rating Scale (MADRS) total score

9 secondary outcomes

Number of Adverse Events
Time frame: From randomisation to follow-up (week 24)
Change From Randomisation in Clinical Global Impression During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Change From Randomisation in Social Adaptation During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Response During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Sustained Response During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Remission During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Sustained Remission During the Randomised Treatment
Time frame: From randomisation to end of treatment (week 20)
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Time frame: From randomisation to end of treatment (week 20)

Results and safety

Results posted to the registry on 3 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period 1 Placebo and ADT	129	27
Period 2 Placebo and ADT	0	0
Period 2 Brexpiprazole 1 mg and ADT	0	0
Period 2 Brexpiprazole 3 mg and ADT	0	0
Period 3 Placebo and ADT	0	0

Primary outcome: Change From Randomisation in Depressive Symptoms During the Randomised Treatment

Time frame: From randomisation to end of treatment (week 20)

Population analysed: Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From randomization to follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 2 Placebo and ADT	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Period 2 Brexpiprazole 1 mg and ADT	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Period 2 Brexpiprazole 3 mg and ADT	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Limitations and caveats (from the sponsor): Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
EMA EudraCT Result PostingLink provided by the sponsor.

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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brexpiprazole 1 mg and Brexpiprazole 3 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 2 sites in United States.

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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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 3 Mar 2016). 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 Randomisation in Depressive Symptoms During the Randomised Treatment (time frame: From randomisation to end of treatment (week 20)). 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 NCT01837797.

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 17 Oct 2018.