Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Last updated: July 11, 2017
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

3

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

N/A

Clinical Study ID

NCT01838681
14570A
2012-001380-76
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is an outpatient consulting a psychiatrist.

  • The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major DepressiveEpisode (MDE) should be confirmed using the Mini International NeuropsychiatricInterview (MINI).

  • The patient has a moderate to severe depression and an insufficient response to atleast one and no more than three adequate antidepressant treatments.

  • The patient agrees to protocol-defined use of effective contraception.

Exclusion

Exclusion Criteria:

  • 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 psychoticsymptomatology in the current MDE.

  • The patient suffers from mental retardation, organic mental disorders, or mentaldisorders due to a general medical condition (DSM-IV-TR™ criteria).

  • The patient, in the opinion of the investigator or according to Columbia-SuicideSeverity Rating Scale (C-SSRS), is at significant risk of suicide.

  • The patient has had neuroleptic malignant syndrome.

  • 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'sopinion, clinically significant.

  • The patient has a history of cancer, other than basal cell or Stage 1 squamous cellcarcinoma of the skin, that has not been in remission for >5 years prior to the firstdose of IMP.

  • The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason. Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 1986
Study Start date:
June 01, 2013
Estimated Completion Date:
June 30, 2016

Study 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.

Connect with a study center

  • BG007

    Kardjali,
    Bulgaria

    Site Not Available

  • BG002

    Pazardzhik,
    Bulgaria

    Site Not Available

  • BG003

    Ruse,
    Bulgaria

    Site Not Available

  • BG001

    Sofia,
    Bulgaria

    Site Not Available

  • BG004

    Sofia,
    Bulgaria

    Site Not Available

  • BG005

    Varna,
    Bulgaria

    Site Not Available

  • BG006

    Varna,
    Bulgaria

    Site Not Available

  • CA003

    Burlington,
    Canada

    Site Not Available

  • CA004

    Edmonton, Alberta,
    Canada

    Site Not Available

  • CA001

    Kingston,
    Canada

    Site Not Available

  • CA002

    Montral,
    Canada

    Site Not Available

  • CA005

    Montreal,
    Canada

    Site Not Available

  • EE002

    Tallinn,
    Estonia

    Site Not Available

  • EE003

    Tallinn,
    Estonia

    Site Not Available

  • EE006

    Tallinn,
    Estonia

    Site Not Available

  • EE001

    Tartu,
    Estonia

    Site Not Available

  • EE005

    Tartu,
    Estonia

    Site Not Available

  • EE004

    Voru,
    Estonia

    Site Not Available

  • FI002

    Helsinki,
    Finland

    Site Not Available

  • FI003

    Helsinki,
    Finland

    Site Not Available

  • FI006

    Helsinki,
    Finland

    Site Not Available

  • FI001

    Kuopio,
    Finland

    Site Not Available

  • FI007

    Pori,
    Finland

    Site Not Available

  • FI009

    Tampere,
    Finland

    Site Not Available

  • DE007

    Berlin,
    Germany

    Site Not Available

  • DE014

    Berlin,
    Germany

    Site Not Available

  • DE015

    Berlin,
    Germany

    Site Not Available

  • DE006

    Bielefeld,
    Germany

    Site Not Available

  • DE010

    Bochum,
    Germany

    Site Not Available

  • DE012

    Gelsenkirchen,
    Germany

    Site Not Available

  • DE009

    Hannover,
    Germany

    Site Not Available

  • DE022

    Hattingen,
    Germany

    Site Not Available

  • DE008

    Heidelberg,
    Germany

    Site Not Available

  • DE017

    Leipzig,
    Germany

    Site Not Available

  • DE001

    Nuernberg,
    Germany

    Site Not Available

  • DE004

    Nuernberg,
    Germany

    Site Not Available

  • DE002

    Schwerin,
    Germany

    Site Not Available

  • DE016

    Wiesbaden,
    Germany

    Site Not Available

  • IT001

    Brescia,
    Italy

    Site Not Available

  • KR009

    Bucheon-si,
    Korea, Republic of

    Site Not Available

  • KR008

    Gwangju,
    Korea, Republic of

    Site Not Available

  • KR002

    Incheon,
    Korea, Republic of

    Site Not Available

  • KR007

    Seongnam-si,
    Korea, Republic of

    Site Not Available

  • KR001

    Seoul,
    Korea, Republic of

    Site Not Available

  • KR004

    Seoul,
    Korea, Republic of

    Site Not Available

  • LV004

    Daugavpils,
    Latvia

    Site Not Available

  • LV005

    Jelgava,
    Latvia

    Site Not Available

  • LV002

    Liepaja,
    Latvia

    Site Not Available

  • LV003

    Riga,
    Latvia

    Site Not Available

  • LV001

    Strenci,
    Latvia

    Site Not Available

  • LT003

    Kaunas,
    Lithuania

    Site Not Available

  • LT006

    Kaunas Region,
    Lithuania

    Site Not Available

  • LT001

    Palanga,
    Lithuania

    Site Not Available

  • LT005

    Silute,
    Lithuania

    Site Not Available

  • LT002

    Vilnius,
    Lithuania

    Site Not Available

  • LT004

    Vilnius,
    Lithuania

    Site Not Available

  • MX009

    Guadalajara,
    Mexico

    Site Not Available

  • MX008

    Leon,
    Mexico

    Site Not Available

  • MX002

    Monterrey,
    Mexico

    Site Not Available

  • MX003

    Monterrey, Nuevo Len,
    Mexico

    Site Not Available

  • PL010

    Bialystok,
    Poland

    Site Not Available

  • PL016

    Bialystok,
    Poland

    Site Not Available

  • PL017

    Bydgoszcz,
    Poland

    Site Not Available

  • PL007

    Chelmno,
    Poland

    Site Not Available

  • PL002

    Gdansk,
    Poland

    Site Not Available

  • PL011

    Gorlice,
    Poland

    Site Not Available

  • PL018

    Kielce,
    Poland

    Site Not Available

  • PL013

    Leszno,
    Poland

    Site Not Available

  • PL001

    Lublin,
    Poland

    Site Not Available

  • PL006

    Lublin,
    Poland

    Site Not Available

  • PL004

    Skorzewo,
    Poland

    Site Not Available

  • PL014

    Szczecin,
    Poland

    Site Not Available

  • PL012

    Torun,
    Poland

    Site Not Available

  • PL019

    Torun,
    Poland

    Site Not Available

  • RO003

    Bucuresti,
    Romania

    Site Not Available

  • RO006

    Bucuresti,
    Romania

    Site Not Available

  • RO001

    Iasi,
    Romania

    Site Not Available

  • RO004

    Timisoara,
    Romania

    Site Not Available

  • RU002

    Moscow,
    Russian Federation

    Site Not Available

  • RU004

    Moscow,
    Russian Federation

    Site Not Available

  • RU003

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • RU006

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • RU007

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • RU010

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • RU014

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • RU012

    Saratov,
    Russian Federation

    Site Not Available

  • RU005

    Stavropol,
    Russian Federation

    Site Not Available

  • SE008

    Halmstad,
    Sweden

    Site Not Available

  • SE006

    Malm,
    Sweden

    Site Not Available

  • SE006

    Malmo,
    Sweden

    Site Not Available

  • SE009

    Skovde,
    Sweden

    Site Not Available

  • SE001

    Stockholm,
    Sweden

    Site Not Available

  • UA006

    Kharkiv,
    Ukraine

    Site Not Available

  • UA007

    Kherson,Vil. Stepanivka,
    Ukraine

    Site Not Available

  • UA003

    Kiev,
    Ukraine

    Site Not Available

  • UA014

    Kiev,
    Ukraine

    Site Not Available

  • UA002

    Kyiv,
    Ukraine

    Site Not Available

  • UA005

    Lviv,
    Ukraine

    Site Not Available

  • UA012

    Ternopil,
    Ukraine

    Site Not Available

  • UA009

    Vinnytsya,
    Ukraine

    Site Not Available

  • GB003

    Blackpool,
    United Kingdom

    Site Not Available

  • GB005

    Bognor Regis,
    United Kingdom

    Site Not Available

  • GB002

    Bradford,
    United Kingdom

    Site Not Available

  • GB004

    Cannock,
    United Kingdom

    Site Not Available

  • GB001

    Leeds,
    United Kingdom

    Site Not Available

  • GB006

    Winwick,
    United Kingdom

    Site Not Available

  • US041

    Little Rock, Arkansas
    United States

    Site Not Available

  • US043

    Cerritos, California
    United States

    Site Not Available

  • US042

    Temecula, California
    United States

    Site Not Available

  • US042

    Ternecula, California
    United States

    Site Not Available

  • US053

    Flowood, Mississippi
    United States

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  • US040

    Brooklyn, New York
    United States

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  • US046

    Houston, Texas
    United States

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  • US052

    Houston, Texas
    United States

    Site Not Available

  • US044

    Herndon, Virginia
    United States

    Site Not Available

  • US047

    Milwaukee, Wisconsin
    United States

    Site Not Available

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