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

NCT01838681 | Completed Phase 3 Results

• 2 other identifiers: 14570A2012-001380-76
• Study Type: interventional
• Target: 1,986
• Locations: 16 countries
• Sites: 107

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomisation to end of Period B (24 weeks)

Secondary Outcomes (17)

• Full Functional Remission During the Randomised Treatment Period

  From randomisation to end of Period B (24 weeks)

• Full Global Score Remission During the Randomised Treatment Period

  From randomisation to end of Period B (24 weeks)

• Total Time in Remission During the Randomised Treatment Period

  From randomisation to end of Period B (24 weeks)

• Time to Full Remission During the Randomised Treatment Period

  From randomisation to end of Period B (24 weeks)

• Full Remission Sustained During the Randomised Treatment Period

  From randomisation to end of Period B (24 weeks)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: ADT

Brexpiprazole

EXPERIMENTAL

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

Drug: Brexpiprazole; Drug: ADT

Interventions

Placebo DRUG

Once daily, tablets, orally

Placebo

Brexpiprazole DRUG

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

Brexpiprazole

ADT DRUG

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

Brexpiprazole; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (107)

US041

Little Rock, Arkansas, United States

Location

US043

Cerritos, California, United States

Location

US042

Temecula, California, United States

Location

US053

Flowood, Mississippi, United States

Location

US040

Brooklyn, New York, United States

Location

US046

Houston, Texas, United States

Location

US052

Houston, Texas, United States

Location

US047

Milwaukee, Wisconsin, United States

Location

BG007

Kardzhali, Bulgaria

Location

BG002

Pazardzhik, Bulgaria

Location

BG003

Rousse, Bulgaria

Location

BG001

Sofia, Bulgaria

Location

BG004

Sofia, Bulgaria

Location

BG005

Varna, Bulgaria

Location

BG006

Varna, Bulgaria

Location

CA003

Burlington, Canada

Location

CA004

Edmonton, Alberta, Canada

Location

CA001

Kingston, Canada

Location

CA002

Montral, Canada

Location

CA005

Montreal, Canada

Location

EE002

Tallinn, Estonia

Location

EE003

Tallinn, Estonia

Location

EE006

Tallinn, Estonia

Location

EE001

Tartu, Estonia

Location

EE005

Tartu, Estonia

Location

EE004

Võru, Estonia

Location

FI002

Helsinki, Finland

Location

FI003

Helsinki, Finland

Location

FI006

Helsinki, Finland

Location

FI001

Kuopio, Finland

Location

FI007

Pori, Finland

Location

FI009

Tampere, Finland

Location

DE007

Berlin, Germany

Location

DE014

Berlin, Germany

Location

DE015

Berlin, Germany

Location

DE006

Bielefeld, Germany

Location

DE010

Bochum, Germany

Location

DE012

Gelsenkirchen, Germany

Location

DE009

Hanover, Germany

Location

DE022

Hattingen, Germany

Location

DE008

Heidelberg, Germany

Location

DE017

Leipzig, Germany

Location

DE001

Nuremberg, Germany

Location

DE004

Nuremberg, Germany

Location

DE002

Schwerin, Germany

Location

DE016

Wiesbaden, Germany

Location

LV004

Daugavpils, Latvia

Location

LV005

Jelgava, Latvia

Location

LV002

Liepāja, Latvia

Location

LV003

Riga, Latvia

Location

LV001

Strenči, Latvia

Location

LT003

Kaunas, Lithuania

Location

LT006

Kaunas Region, Lithuania

Location

LT001

Palanga, Lithuania

Location

LT005

Šilutė, Lithuania

Location

LT002

Vilnius, Lithuania

Location

LT004

Vilnius, Lithuania

Location

MX009

Guadalajara, Mexico

Location

MX008

León, Mexico

Location

MX002

Monterrey, Mexico

Location

MX003

Monterrey, Nuevo Len, Mexico

Location

PL010

Bialystok, Poland

Location

PL016

Bialystok, Poland

Location

PL017

Bydgoszcz, Poland

Location

PL007

Chełmno, Poland

Location

PL002

Gdansk, Poland

Location

PL011

Gorlice, Poland

Location

PL018

Kielce, Poland

Location

PL013

Leszno, Poland

Location

PL001

Lublin, Poland

Location

PL006

Lublin, Poland

Location

PL014

Szczecin, Poland

Location

PL012

Torun, Poland

Location

PL019

Torun, Poland

Location

RO003

Bucharest, Romania

Location

RO006

Bucharest, Romania

Location

RO001

Iași, Romania

Location

RO004

Timișoara, Romania

Location

RU002

Moscow, Russia

Location

RU004

Moscow, Russia

Location

RU003

Saint Petersburg, Russia

Location

RU006

Saint Petersburg, Russia

Location

RU007

Saint Petersburg, Russia

Location

RU010

Saint Petersburg, Russia

Location

RU014

Saint Petersburg, Russia

Location

RU012

Saratov, Russia

Location

RU005

Stavropol, Russia

Location

KR001

Seoul, South Korea

Location

KR004

Seoul, South Korea

Location

SE008

Halmstad, Sweden

Location

SE006

Malmo, Sweden

Location

SE009

Skövde, Sweden

Location

SE001

Stockholm, Sweden

Location

UA006

Kharkiv, Ukraine

Location

UA007

Kherson,Vil. Stepanivka, Ukraine

Location

UA003

Kiev, Ukraine

Location

UA014

Kiev, Ukraine

Location

UA002

Kyiv, Ukraine

Location

UA005

Lviv, Ukraine

Location

UA012

Ternopil, Ukraine

Location

UA009

Vinnytsia, Ukraine

Location

GB003

Blackpool, United Kingdom

Location

GB005

Bognor Regis, United Kingdom

Location

GB002

Bradford, United Kingdom

Location

GB004

Cannock, United Kingdom

Location

GB001

Leeds, United Kingdom

Location

GB006

Winwick, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2013
• First Posted: April 24, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-07

Locations

KR (2); US (8); DE (14); LA (5); PL (13); BU (7); SE (4); RU (9); RO (4); FI (6); LI (6); GB (6); UA (8); ES (6); ME (4); CA (5)