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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838681
• Other study ID #: 14570A
• Secondary ID: 2012-001380-76
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2013
• Last updated: June 17, 2016
• Start date: June 2013

Study information

• Verified date: June 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationItaly: Ministry of HealthKorea: Food and Drug AdministrationRomania: National Agency for Medicines and Medical DevicesUkraine: Ministry of HealthLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the maintenance of efficacy and safety during long-term treatment with brexpiprazole as an adjunctive treatment for adult subjects with Major Depressive Disorder (MDD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1986
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Once daily, tablets, orally
• Brexpiprazole
Up to 3 mg/day, once daily dose, tablets, orally

Locations

Country	Name	City	State
Bulgaria	BG007	Kardjali
Bulgaria	BG002	Pazardzhik
Bulgaria	BG003	Ruse
Bulgaria	BG001	Sofia
Bulgaria	BG004	Sofia
Bulgaria	BG005	Varna
Bulgaria	BG006	Varna
Canada	CA003	Burlington
Canada	CA004	Edmonton, Alberta
Canada	CA001	Kingston
Canada	CA002	Montral
Canada	CA005	Montreal
Estonia	EE002	Tallinn
Estonia	EE003	Tallinn
Estonia	EE006	Tallinn
Estonia	EE001	Tartu
Estonia	EE005	Tartu
Estonia	EE004	Voru
Finland	FI002	Helsinki
Finland	FI003	Helsinki
Finland	FI006	Helsinki
Finland	FI001	Kuopio
Finland	FI007	Pori
Finland	FI009	Tampere
Germany	DE007	Berlin
Germany	DE014	Berlin
Germany	DE015	Berlin
Germany	DE006	Bielefeld
Germany	DE010	Bochum
Germany	DE012	Gelsenkirchen
Germany	DE009	Hannover
Germany	DE022	Hattingen
Germany	DE008	Heidelberg
Germany	DE017	Leipzig
Germany	DE001	Nuernberg
Germany	DE004	Nuernberg
Germany	DE002	Schwerin
Germany	DE016	Wiesbaden
Latvia	LV004	Daugavpils
Latvia	LV005	Jelgava
Latvia	LV002	Liepaja
Latvia	LV003	Riga
Latvia	LV001	Strenci
Lithuania	LT003	Kaunas
Lithuania	LT006	Kaunas Region
Lithuania	LT001	Palanga
Lithuania	LT005	Silute
Lithuania	LT002	Vilnius
Lithuania	LT004	Vilnius
Mexico	MX009	Guadalajara
Mexico	MX008	Leon
Mexico	MX002	Monterrey
Mexico	MX003	Monterrey, Nuevo Len
Poland	PL010	Bialystok
Poland	PL016	Bialystok
Poland	PL017	Bydgoszcz
Poland	PL007	Chelmno
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
Romania	RO003	Bucuresti
Romania	RO006	Bucuresti
Romania	RO001	Iasi
Romania	RO004	Timisoara
Russian Federation	RU002	Moscow
Russian Federation	RU004	Moscow
Russian Federation	RU003	Saint-Petersburg
Russian Federation	RU006	Saint-Petersburg
Russian Federation	RU007	Saint-Petersburg
Russian Federation	RU010	Saint-Petersburg
Russian Federation	RU014	Saint-Petersburg
Russian Federation	RU012	Saratov
Russian Federation	RU005	Stavropol
Sweden	SE008	Halmstad
Sweden	SE006	Malm
Sweden	SE009	Skovde
Sweden	SE001	Stockholm
Ukraine	UA006	Kharkiv
Ukraine	UA007	Kherson,Vil. Stepanivka
Ukraine	UA003	Kiev
Ukraine	UA014	Kiev
Ukraine	UA002	Kyiv
Ukraine	UA005	Lviv
Ukraine	UA012	Ternopil
Ukraine	UA009	Vinnytsya
United Kingdom	GB003	Blackpool
United Kingdom	GB005	Bognor Regis
United Kingdom	GB002	Bradford
United Kingdom	GB004	Cannock
United Kingdom	GB001	Leeds
United Kingdom	GB006	Winwick
United States	US040	Brooklyn	New York
United States	US043	Cerritos	California
United States	US053	Flowood	Mississippi
United States	US046	Houston	Texas
United States	US052	Houston	Texas
United States	US041	Little Rock	Arkansas
United States	US047	Milwaukee	Wisconsin
United States	US042	Ternecula	California

Sponsors (2)

Lead Sponsor	Collaborator
H. Lundbeck A/S	Otsuka Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Estonia,  Finland,  Germany,  Latvia,  Lithuania,  Mexico,  Poland,  Romania,  Russian Federation,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full remission during the randomised treatment period	A pre-specified length of remission based on Montgomery and Åsberg Depression Rating Scale (MADRS) total score	Baseline to 36 weeks	No
Secondary	Full functional remission during the randomised treatment	A pre-specified length of remission based on Sheehan Disability Scale (SDS) total score	Baseline to 36 weeks	No
Secondary	Full global score remission in global clinical impression during the randomised treatment	A pre-specified length of remission based on Clinical Global Impression - Severity of Illness (CGI-S) score	Baseline to 36 weeks	No
Secondary	Change from randomisation in depressive symptoms during the randomised treatment	MADRS total score	Baseline to 36 weeks	No
Secondary	Response during the randomised treatment	Based on pre-specified decrease in MADRS total score	Baseline to 36 weeks	No
Secondary	Remission during the randomised treatment	Based on a pre-specified MADRS total score	Baseline to 36 weeks	No
Secondary	Total time in remission during the randomised treatment	The total time the patient spends in remission during randomised treatment	Baseline to 36 weeks	No
Secondary	Time to full remission during the randomised treatment	The time until full remission has been obtained	Baseline to 36 weeks	No
Secondary	Change from randomisation in clinical global impression during the randomised treatment	CGI-S score	Baseline to 36 weeks	No
Secondary	Change from randomisation in functionality	SDS total score	Baseline to 36 weeks	No
Secondary	Change from randomisation in health-related quality of life	Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) total score	Baseline to 36 weeks	No
Secondary	Safety and tolerability	Number of adverse events	Up to 36 weeks and a 4-week safety follow up	Yes
Secondary	Risk of suicidality	Columbia-Suicide Severity Rating Scale (C-SSRS) score	Up to 36 weeks	Yes