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

NCT ID: NCT01838681

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1986 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-06-30

Brief 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).

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 Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once daily, tablets, orally

ADT

Intervention Type: DRUG

Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label

Brexpiprazole

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day

ADT

Intervention Type: DRUG

Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label

Interventions

Placebo

Once daily, tablets, orally

Intervention Type: DRUG

Brexpiprazole

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day

Intervention Type: DRUG

ADT

Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

US041

Little Rock, Arkansas, United States

US043

Cerritos, California, United States

US042

Temecula, California, United States

US053

Flowood, Mississippi, United States

US040

Brooklyn, New York, United States

US046

Houston, Texas, United States

US052

Houston, Texas, United States

US047

Milwaukee, Wisconsin, United States

BG007

Kardzhali, , Bulgaria

BG002

Pazardzhik, , Bulgaria

BG003

Rousse, , Bulgaria

BG001

Sofia, , Bulgaria

BG004

Sofia, , Bulgaria

BG005

Varna, , Bulgaria

BG006

Varna, , Bulgaria

CA003

Burlington, , Canada

CA004

Edmonton, Alberta, , Canada

CA001

Kingston, , Canada

CA002

Montral, , Canada

CA005

Montreal, , Canada

EE002

Tallinn, , Estonia

EE003

Tallinn, , Estonia

EE006

Tallinn, , Estonia

EE001

Tartu, , Estonia

EE005

Tartu, , Estonia

EE004

Võru, , Estonia

FI002

Helsinki, , Finland

FI003

Helsinki, , Finland

FI006

Helsinki, , Finland

FI001

Kuopio, , Finland

FI007

Pori, , Finland

FI009

Tampere, , Finland

DE007

Berlin, , Germany

DE014

Berlin, , Germany

DE015

Berlin, , Germany

DE006

Bielefeld, , Germany

DE010

Bochum, , Germany

DE012

Gelsenkirchen, , Germany

DE009

Hanover, , Germany

DE022

Hattingen, , Germany

DE008

Heidelberg, , Germany

DE017

Leipzig, , Germany

DE001

Nuremberg, , Germany

DE004

Nuremberg, , Germany

DE002

Schwerin, , Germany

DE016

Wiesbaden, , Germany

LV004

Daugavpils, , Latvia

LV005

Jelgava, , Latvia

LV002

Liepāja, , Latvia

LV003

Riga, , Latvia

LV001

Strenči, , Latvia

LT003

Kaunas, , Lithuania

LT006

Kaunas Region, , Lithuania

LT001

Palanga, , Lithuania

LT005

Šilutė, , Lithuania

LT002

Vilnius, , Lithuania

LT004

Vilnius, , Lithuania

MX009

Guadalajara, , Mexico

MX008

León, , Mexico

MX002

Monterrey, , Mexico

MX003

Monterrey, Nuevo Len, , Mexico

PL010

Bialystok, , Poland

PL016

Bialystok, , Poland

PL017

Bydgoszcz, , Poland

PL007

Chełmno, , Poland

PL002

Gdansk, , Poland

PL011

Gorlice, , Poland

PL018

Kielce, , Poland

PL013

Leszno, , Poland

PL001

Lublin, , Poland

PL006

Lublin, , Poland

PL014

Szczecin, , Poland

PL012

Torun, , Poland

PL019

Torun, , Poland

RO003

Bucharest, , Romania

RO006

Bucharest, , Romania

RO001

Iași, , Romania

RO004

Timișoara, , Romania

RU002

Moscow, , Russia

RU004

Moscow, , Russia

RU003

Saint Petersburg, , Russia

RU006

Saint Petersburg, , Russia

RU007

Saint Petersburg, , Russia

RU010

Saint Petersburg, , Russia

RU014

Saint Petersburg, , Russia

RU012

Saratov, , Russia

RU005

Stavropol, , Russia

KR001

Seoul, , South Korea

KR004

Seoul, , South Korea

SE008

Halmstad, , Sweden

SE006

Malmo, , Sweden

SE009

Skövde, , Sweden

SE001

Stockholm, , Sweden

UA006

Kharkiv, , Ukraine

UA007

Kherson,Vil. Stepanivka, , Ukraine

UA003

Kiev, , Ukraine

UA014

Kiev, , Ukraine

UA002

Kyiv, , Ukraine

UA005

Lviv, , Ukraine

UA012

Ternopil, , Ukraine

UA009

Vinnytsia, , Ukraine

GB003

Blackpool, , United Kingdom

GB005

Bognor Regis, , United Kingdom

GB002

Bradford, , United Kingdom

GB004

Cannock, , United Kingdom

GB001

Leeds, , United Kingdom

GB006

Winwick, , United Kingdom

Countries

United States; Bulgaria; Canada; Estonia; Finland; Germany; Latvia; Lithuania; Mexico; Poland; Romania; Russia; South Korea; Sweden; Ukraine; United Kingdom

Other Identifiers

2012-001380-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14570A

Identifier Type: -

Identifier Source: org_study_id