Major Depressive DisorderPhase 3NCT01838681
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
A Phase 3 study testing Brexpiprazole and ADT in people with Major Depressive Disorder, run by H. Lundbeck A/S at 107 sites in 16 countries.
Trial summary
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD). 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?
- Brexpiprazole and ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,986 participants
- Where
- 107 sitesin 16 countries
- Study dates
- Jun 2013to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is an outpatient consulting a psychiatrist.
- The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
- The patient agrees to protocol-defined use of effective contraception.
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.
Show all 11Show fewer
- The patient has any relevant medical history or current presence of systemic disease.
- 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
107 sites in 16 countries.
107 sites in 16 countries
Germany14 sites
DE007
Berlin
DE014
Berlin
DE015
Berlin
DE006
Bielefeld
DE010
Bochum
DE012
Gelsenkirchen
DE009
Hanover
DE022
Hattingen
DE008
Heidelberg
DE017
Leipzig
DE001
Nuremberg
DE004
Nuremberg
DE002
Schwerin
DE016
Wiesbaden
Poland13 sites
PL010
Bialystok
PL016
Bialystok
PL017
Bydgoszcz
PL007
Chełmno
PL002
Gdansk
PL011
Gorlice
PL018
Kielce
PL013
Leszno
PL001
Lublin
PL006
Lublin
PL014
Szczecin
PL012
Torun
PL019
Torun
Russia9 sites
RU002
Moscow
RU004
Moscow
RU003
Saint Petersburg
RU006
Saint Petersburg
RU007
Saint Petersburg
RU010
Saint Petersburg
RU014
Saint Petersburg
RU012
Saratov
RU005
Stavropol
United States8 sites
US040
Brooklyn, New York
US043
Cerritos, California
US053
Flowood, Mississippi
US046
Houston, Texas
US052
Houston, Texas
US041
Little Rock, Arkansas
US047
Milwaukee, Wisconsin
US042
Temecula, California
Ukraine8 sites
UA006
Kharkiv
UA007
Kherson,Vil. Stepanivka
UA003
Kiev
UA014
Kiev
UA002
Kyiv
UA005
Lviv
UA012
Ternopil
UA009
Vinnytsia
Bulgaria7 sites
BG007
Kardzhali
BG002
Pazardzhik
BG003
Rousse
BG001
Sofia
BG004
Sofia
BG005
Varna
BG006
Varna
Estonia6 sites
EE002
Tallinn
EE003
Tallinn
EE006
Tallinn
EE001
Tartu
EE005
Tartu
EE004
Võru
Finland6 sites
FI002
Helsinki
FI003
Helsinki
FI006
Helsinki
FI001
Kuopio
FI007
Pori
FI009
Tampere
Lithuania6 sites
LT003
Kaunas
LT006
Kaunas Region
LT001
Palanga
LT005
Šilutė
LT002
Vilnius
LT004
Vilnius
United Kingdom6 sites
GB003
Blackpool
GB005
Bognor Regis
GB002
Bradford
GB004
Cannock
GB001
Leeds
GB006
Winwick
Canada5 sites
CA003
Burlington
CA004
Edmonton, Alberta
CA001
Kingston
CA002
Montral
CA005
Montreal
Latvia5 sites
LV004
Daugavpils
LV005
Jelgava
LV002
Liepāja
LV003
Riga
LV001
Strenči
Mexico4 sites
MX009
Guadalajara
MX008
León
MX002
Monterrey
MX003
Monterrey, Nuevo Len
About this study
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Long-term Study to Evaluate the Maintenance of Efficacy and Safety of 1 to 3 mg/Day of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Read the detailed description
The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, Brexpiprazole, ADT
- 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
BrexpiprazoleDrug
1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day
ADTDrug
Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) Receives: Drug: Placebo; Drug: ADT |
| Brexpiprazole | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available ADT Receives: Drug: Brexpiprazole; Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Remission During the Randomised Treatment Period
Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Measured: From randomisation to end of Period B (24 weeks)
Secondary outcomes (17)
Full Functional Remission During the Randomised Treatment Period
Full functional remission is defined as a Sheehan Disability Scale (SDS) total score <=6 and all SDS domain scores <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Measured: From randomisation to end of Period B (24 weeks)
Full Global Score Remission During the Randomised Treatment Period
Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: From randomisation to end of Period B (24 weeks)
Total Time in Remission During the Randomised Treatment Period
The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started.
Measured: From randomisation to end of Period B (24 weeks)
Time to Full Remission During the Randomised Treatment Period
The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods.
Measured: From randomisation to end of Period B (24 weeks)
Full Remission Sustained During the Randomised Treatment Period
Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment.
Measured: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Measured: From randomisation to week 6
Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Measured: From randomisation to end of Period B (24 weeks)
Response at Week 6 During the Randomised Treatment Period
Response is defined as a >=50% decrease from randomisation in MADRS total score.
Measured: From randomisation to week 6
Response at Week 24 During the Randomised Treatment Period
Response is defined as a >=50% decrease from randomisation in MADRS total score.
Measured: From randomisation to end of Period B (24 weeks)
Remission at Week 6 During the Randomised Treatment Period
Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Measured: From randomisation to week 6
Remission at Week 24 in the Randomised Treatment Period
Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Measured: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period
The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Measured: From randomisation to week 6
Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period
The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Measured: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period
The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: From randomisation to week 6
Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period
The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Measured: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.
Measured: From randomisation to week 6
Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period
The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.
Measured: From randomisation to end of Period B (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJun 2013
- 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.
- 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
- 1,986 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838681
- Sponsor's protocol ID
- 14570A
- Other IDs
- 2012-001380-76
- Status last verified
- Jul 2017
- First submitted
- 20 Apr 2013
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Long-term Study to Evaluate the Maintenance of Efficacy and Safety of 1 to 3 mg/Day of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT01838681
- Acronym / sponsor ID
- 14570A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,986 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 9 Aug 2017
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 long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Detailed description
The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.
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, Drug: ADTPlacebo adjunct to open-label treatment with a commercially available antidepressant (ADT) |
| Brexpiprazole | Experimental | Drug: Brexpiprazole, Drug: ADTBrexpiprazole adjunct to open-label treatment with a commercially available ADT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is an outpatient consulting a psychiatrist.
- The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
- The patient agrees to protocol-defined use of effective contraception.
Key exclusion criteria (11 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 |
| Brexpiprazole1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day | Drug | Brexpiprazole |
| ADTDuloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label | Drug | Brexpiprazole, Placebo |
Primary outcome
Full Remission During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
17 secondary outcomes
Full Functional Remission During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Full Global Score Remission During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Total Time in Remission During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Time to Full Remission During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Full Remission Sustained During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
Time frame: From randomisation to week 6
Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Response at Week 6 During the Randomised Treatment Period
Time frame: From randomisation to week 6
Response at Week 24 During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Remission at Week 6 During the Randomised Treatment Period
Time frame: From randomisation to week 6
Remission at Week 24 in the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period
Time frame: From randomisation to week 6
Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period
Time frame: From randomisation to week 6
Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
Time frame: From randomisation to week 6
Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period
Time frame: From randomisation to end of Period B (24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
107 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brexpiprazole and ADT in people with Major Depressive Disorder, run by H. Lundbeck A/S at 107 sites in 16 countries.
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 4 inclusion and 11 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 9 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 107 sites in Germany, Poland, Russia, United States, Ukraine and 11 more countries. 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 9 Aug 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?
Full Remission During the Randomised Treatment Period (time frame: From randomisation to end of Period B (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017.