Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

Major Depression Disorder Clinical Trial

Official title:

Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400346
• Other study ID #: 16160A
• Secondary ID: 2014-003547-35
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2015
• Last updated: June 6, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Main Inclusion Criteria:

• • The patient is a man or woman aged =65 yrs

• The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).

• The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE).

• The patient has had the current MDE for =8 weeks

• The patient is currently treated with a protocol specified ADT for at least 6 weeks

• The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.

• Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline

• Clinical Global Impression - Severity (CGI-S) total score =3 at screening and baseline

Main Exclusion Criteria:

• • The patient has a clinically significant unstable illness

• The patient has newly diagnosed or unstable diabetes

• The patient has a Mini Mental State Exam (MMSE) score <24

• The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening.

• The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide

Other protocol defined inclusion and exclusion criteria may apply

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Adjunct brexpiprazole
Weeks 1-4: titration from 0.5 up to 2 mg once daily. Weeks 4-26: Maintenance with 1-3 mg once daily. Tablets for oral use once daily during 26 weeks. Tablet strenghts: 0.5 mg, 1 mg, 2 mg and 3 mg.

Locations

Country	Name	City	State
Estonia	EE002	Tallinn
Estonia	EE001	Tartu
Estonia	EE004	Tartu
Estonia	EE003	Voru
Finland	FI001	Helsinki
Finland	FI002	Kuopio
Finland	FI003	Oulu
Finland	FI004	Tampere
Germany	DE002	Berlin
Germany	DE008	Berlin
Germany	DE003	Frankfurt
Germany	DE007	Hannover
Germany	DE006	Mittweida
Germany	DE001	Schwerin
Germany	DE005	Wiesbaden
Poland	PL006	Bialystok
Poland	PL003	Bydgoszcz
Poland	PL001	Chelmno
Poland	PL005	Gdansk
Poland	PL004	Lublin
Poland	PL002	Pruszcz Gdanski
United States	US009	Allentown	Pennsylvania
United States	US012	Arcadia	California
United States	US001	Memphis	Tennessee
United States	US004	Miami	Florida
United States	US005	New York	New York
United States	US008	New York	New York
United States	US002	O'Fallon	Missouri
United States	US014	Oklahoma City	Oklahoma
United States	US007	Orlando	Florida
United States	US011	San Antonio	Texas
United States	US006	Smyrna	Georgia
United States	US003	Staten Island	New York
United States	US010	Toms River	New Jersey
United States	US013	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		Week 30	Yes