Major Depression Disorder
Conditions
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
Interventions
DRUGAdjunct 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.
DRUGADT
Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Estonia, Finland, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adjunct Brexpiprazole All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: 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. | 132 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative or other reason(s) | 2 |
| Overall Study | Adverse Event | 24 |
| Overall Study | Lack of Efficacy | 9 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Non-compliance with IMP | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Adjunct Brexpiprazole |
|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 5.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 130 Participants |
| Region of Enrollment Estonia | 21 Participants |
| Region of Enrollment Finland | 27 Participants |
| Region of Enrollment Germany | 15 Participants |
| Region of Enrollment Poland | 17 Participants |
| Region of Enrollment United States | 52 Participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 132 |
| other Total, other adverse events | 79 / 132 |
| serious Total, serious adverse events | 6 / 132 |
Outcome results
Primary
Number of Patients With Treatment-Emergent Adverse Events
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Time frame: Baseline to 30 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adjunct Brexpiprazole | Number of Patients With Treatment-Emergent Adverse Events | 102 Participants |