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

• Register: EUCTR
• Last refreshed on: 29 August 2016
• Main ID: EUCTR2014-003547-35-FI
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
• Scientific 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 - N/A
• Date of first enrolment: 07/04/2015
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003547-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: adjunct treatment to open-label, oral, commercially available If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Finland, Germany, Poland, United States

Contacts

• Name: [e-mail]
• Affiliation: H. Lundbeck A/S

• Name: [e-mail]
• Affiliation: H. Lundbeck A/S

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder
MedDRA version: 17.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873
MedDRA version: 17.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

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 descriptive name: BREXPIPRAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-

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 descriptive name: BREXPIPRAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

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 descriptive name: BREXPIPRAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

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 descriptive name: BREXPIPRAZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At all study visits - please refer to study protocol

Primary end point(s): Long-term safety and tolerability - please refer to study protocol

Secondary Objective: Not applicable

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

16160A

2014-003547-35-EE

Source(s) of Monetary Support

H. Lundbeck A/S