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

Phase 3

Completed

• Conditions: Major Depression Disorder
• Interventions: Drug: Adjunct brexpiprazole; Drug: ADT

• Registration Number: NCT02400346
• Lead Sponsor: H. Lundbeck A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-06-02
• Results First Submitted QC: 2017-06-02
• Results First Posted: 2017-06-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjunct brexpiprazole	Adjunct brexpiprazole	All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
Adjunct brexpiprazole	ADT	All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition

Primary Outcome Measures

Name	Time	Method
Number of Patients With Treatment-Emergent Adverse Events	Baseline to 30 weeks	Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit

Trial Locations

Locations (34)

FI003; 🇫🇮 Oulu, Finland

DE001; 🇩🇪 Schwerin, Germany

DE008; 🇩🇪 Berlin, Germany

PL005; 🇵🇱 Gdansk, Poland

PL004; 🇵🇱 Lublin, Poland

US012; 🇺🇸 Arcadia, California, United States

PL002; 🇵🇱 Pruszcz Gdanski, Poland

DE006; 🇩🇪 Mittweida, Germany

US002; 🇺🇸 O'Fallon, Missouri, United States

US005; 🇺🇸 New York, New York, United States

EE003; 🇪🇪 Voru, Estonia

PL001; 🇵🇱 Chelmno, Poland

DE007; 🇩🇪 Hannover, Germany

US006; 🇺🇸 Smyrna, Georgia, United States

EE004; 🇪🇪 Tartu, Estonia

FI004; 🇫🇮 Tampere, Finland

PL006; 🇵🇱 Bialystok, Poland

DE002; 🇩🇪 Berlin, Germany

PL003; 🇵🇱 Bydgoszcz, Poland

US008; 🇺🇸 New York, New York, United States

EE001; 🇪🇪 Tartu, Estonia

FI001; 🇫🇮 Helsinki, Finland

DE005; 🇩🇪 Wiesbaden, Germany

US004; 🇺🇸 Miami, Florida, United States

US003; 🇺🇸 Staten Island, New York, United States

US009; 🇺🇸 Allentown, Pennsylvania, United States

US011; 🇺🇸 San Antonio, Texas, United States

FI002; 🇫🇮 Kuopio, Finland

EE002; 🇪🇪 Tallinn, Estonia

DE003; 🇩🇪 Frankfurt, Germany

US007; 🇺🇸 Orlando, Florida, United States

US001; 🇺🇸 Memphis, Tennessee, United States

US010; 🇺🇸 Toms River, New Jersey, United States

US014; 🇺🇸 Oklahoma City, Oklahoma, United States