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

PHASE3CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Major Depression Disorder
Interventions
DRUG

Adjunct brexpiprazole

"Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."

DRUG

ADT

Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label

Trial Locations (34)

Unknown

US012, Arcadia

US004, Miami

US007, Orlando

US006, Smyrna

US002, O'Fallon

US010, Toms River

US005, New York

US008, New York

US003, Staten Island

US014, Oklahoma City

US009, Allentown

US001, Memphis

US011, San Antonio

EE002, Tallinn

EE001, Tartu

EE004, Tartu

EE003, Võru

FI001, Helsinki

FI002, Kuopio

FI003, Oulu

FI004, Tampere

DE002, Berlin

DE008, Berlin

DE003, Frankfurt

DE007, Hanover

DE006, Mittweida

DE001, Schwerin

DE005, Wiesbaden

PL006, Bialystok

PL003, Bydgoszcz

PL001, Chełmno

PL005, Gdansk

PL004, Lublin

PL002, Pruszcz Gdański

All Listed Sponsors
lead

H. Lundbeck A/S

INDUSTRY

NCT02400346 - Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment | Biotech Hunter | Biotech Hunter