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

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

NCT02400346•H. Lundbeck A/S

View on ClinicalTrials.gov

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

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (34)

US012

Arcadia, California, United States

US004

Miami, Florida, United States

US007

Orlando, Florida, United States

US006

Smyrna, Georgia, United States

US002

O'Fallon, Missouri, United States

US010

Toms River, New Jersey, United States

US005

New York, New York, United States

US008

New York, New York, United States

US003

Staten Island, New York, United States

US014

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

August 10, 2017

Enrollment

132

ACTUAL participants

Conditions

Major Depression Disorder

Interventions

Adjunct brexpiprazole

DRUG

ADT

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Neuromodulation and Attention Deficits in MDD

An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms

Comparison of Remimazolam and Etomidate As Induction Agents for Electroconvulsive Treatment