Clinical trial NCT01838681: Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-04-24
Enrollment: 1986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study.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

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.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Full Remission During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
Secondary outcomes:
measure: Full Functional Remission During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Full Global Score Remission During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Total Time in Remission During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Time to Full Remission During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Full Remission Sustained During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Response at Week 6 During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: Response at Week 24 During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Remission at Week 6 During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: Remission at Week 24 in the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period
timeFrame: From randomisation to end of Period B (24 weeks)
measure: Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
timeFrame: From randomisation to week 6
measure: 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
timeFrame: From randomisation to end of Period B (24 weeks)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: US041
state: Arkansas
city: Cerritos
country: United States
facility: US043
state: California
city: Temecula
country: United States
facility: US042
state: California
city: Flowood
country: United States
facility: US053
state: Mississippi
city: Brooklyn
country: United States
facility: US040
state: New York
city: Houston
country: United States
facility: US046
state: Texas
city: Houston
country: United States
facility: US052
state: Texas
city: Milwaukee
country: United States
facility: US047
state: Wisconsin
city: Kardjali
country: Bulgaria
facility: BG007
city: Pazardzhik
country: Bulgaria
facility: BG002
city: Ruse
country: Bulgaria
facility: BG003
city: Sofia
country: Bulgaria
facility: BG001
city: Sofia
country: Bulgaria
facility: BG004
city: Varna
country: Bulgaria
facility: BG005
city: Varna
country: Bulgaria
facility: BG006
city: Burlington
country: Canada
facility: CA003
city: Edmonton, Alberta
country: Canada
facility: CA004
city: Kingston
country: Canada
facility: CA001
city: Montral
country: Canada
facility: CA002
city: Montreal
country: Canada
facility: CA005
city: Tallinn
country: Estonia
facility: EE002
city: Tallinn
country: Estonia
facility: EE003
city: Tallinn
country: Estonia
facility: EE006
city: Tartu
country: Estonia
facility: EE001
city: Tartu
country: Estonia
facility: EE005
city: Voru
country: Estonia
facility: EE004
city: Helsinki
country: Finland
facility: FI002
city: Helsinki
country: Finland
facility: FI003
city: Helsinki
country: Finland
facility: FI006
city: Kuopio
country: Finland
facility: FI001
city: Pori
country: Finland
facility: FI007
city: Tampere
country: Finland
facility: FI009
city: Berlin
country: Germany
facility: DE007
city: Berlin
country: Germany
facility: DE014
city: Berlin
country: Germany
facility: DE015
city: Bielefeld
country: Germany
facility: DE006
city: Bochum
country: Germany
facility: DE010
city: Gelsenkirchen
country: Germany
facility: DE012
city: Hannover
country: Germany
facility: DE009
city: Hattingen
country: Germany
facility: DE022
city: Heidelberg
country: Germany
facility: DE008
city: Leipzig
country: Germany
facility: DE017
city: Nuernberg
country: Germany
facility: DE001
city: Nuernberg
country: Germany
facility: DE004
city: Schwerin
country: Germany
facility: DE002
city: Wiesbaden
country: Germany
facility: DE016
city: Seoul
country: Korea, Republic of
facility: KR001
city: Seoul
country: Korea, Republic of
facility: KR004
city: Daugavpils
country: Latvia
facility: LV004
city: Jelgava
country: Latvia
facility: LV005
city: Liepaja
country: Latvia
facility: LV002
city: Riga
country: Latvia
facility: LV003
city: Strenci
country: Latvia
facility: LV001
city: Kaunas Region
country: Lithuania
facility: LT006
city: Kaunas
country: Lithuania
facility: LT003
city: Palanga
country: Lithuania
facility: LT001
city: Silute
country: Lithuania
facility: LT005
city: Vilnius
country: Lithuania
facility: LT002
city: Vilnius
country: Lithuania
facility: LT004
city: Guadalajara
country: Mexico
facility: MX009
city: Leon
country: Mexico
facility: MX008
city: Monterrey, Nuevo Len
country: Mexico
facility: MX003
city: Monterrey
country: Mexico
facility: MX002
city: Bialystok
country: Poland
facility: PL010
city: Bialystok
country: Poland
facility: PL016
city: Bydgoszcz
country: Poland
facility: PL017
city: Chelmno
country: Poland
facility: PL007
city: Gdansk
country: Poland
facility: PL002
city: Gorlice
country: Poland
facility: PL011
city: Kielce
country: Poland
facility: PL018
city: Leszno
country: Poland
facility: PL013
city: Lublin
country: Poland
facility: PL001
city: Lublin
country: Poland
facility: PL006
city: Szczecin
country: Poland
facility: PL014
city: Torun
country: Poland
facility: PL012
city: Torun
country: Poland
facility: PL019
city: Bucuresti
country: Romania
facility: RO003
city: Bucuresti
country: Romania
facility: RO006
city: Iasi
country: Romania
facility: RO001
city: Timisoara
country: Romania
facility: RO004
city: Moscow
country: Russian Federation
facility: RU002
city: Moscow
country: Russian Federation
facility: RU004
city: Saint-Petersburg
country: Russian Federation
facility: RU003
city: Saint-Petersburg
country: Russian Federation
facility: RU006
city: Saint-Petersburg
country: Russian Federation
facility: RU007
city: Saint-Petersburg
country: Russian Federation
facility: RU010
city: Saint-Petersburg
country: Russian Federation
facility: RU014
city: Saratov
country: Russian Federation
facility: RU012
city: Stavropol
country: Russian Federation
facility: RU005
city: Halmstad
country: Sweden
facility: SE008
city: Malmo
country: Sweden
facility: SE006
city: Skovde
country: Sweden
facility: SE009
city: Stockholm
country: Sweden
facility: SE001
city: Kharkiv
country: Ukraine
facility: UA006
city: Kherson,Vil. Stepanivka
country: Ukraine
facility: UA007
city: Kiev
country: Ukraine
facility: UA003
city: Kiev
country: Ukraine
facility: UA014
city: Kyiv
country: Ukraine
facility: UA002
city: Lviv
country: Ukraine
facility: UA005
city: Ternopil
country: Ukraine
facility: UA012
city: Vinnytsya
country: Ukraine
facility: UA009
city: Blackpool
country: United Kingdom
facility: GB003
city: Bognor Regis
country: United Kingdom
facility: GB005
city: Bradford
country: United Kingdom
facility: GB002
city: Cannock
country: United Kingdom
facility: GB004
city: Leeds
country: United Kingdom
facility: GB001
city: Winwick
country: United Kingdom
facility: GB006
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: