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 - N/A

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003547-35-EE

Enrollment

130

Registered

2015-02-02

Start date

2015-04-07

Completion date

Unknown

Last updated

2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder MedDRA version: 18.0 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873 MedDRA version: 18.0 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873

Interventions

Product Name: Brexpiprazole Product Code: Lu AF41156 / OPC-34712 Pharmaceutical Form: Tablet INN or Proposed INN: Brexpiprazole CAS Number: 913611-97-9 Current Sponsor code: Lu AF41156/OPC-34712 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The patient is a man or woman aged =65 years - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At all study visits - please refer to study protocol ;Main Objective: To evaluate the long-term safety and tolerability of brexpiprazole (1 to 3 mg/day) as adjunct treatment to antidepressant treatment (ADT) in elderly patients with MDD;Secondary Objective: Not applicable;Primary end point(s): Long-term safety and tolerability - please refer to study protocol	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At all study visits - please refer to study protocol ;Main Objective: To evaluate the long-term safety and tolerability of brexpiprazole (1 to 3 mg/day) as adjunct treatment to antidepressant treatment (ADT) in elderly patients with MDD;Secondary Objective: Not applicable;Primary end point(s): Long-term safety and tolerability - please refer to study protocol

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Estonia, Finland, Germany, Poland, United States

Contacts

Public ContactLundbeckClinicalTrials@lundbeck.com

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com+4536301311

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026