Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
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| ClinicalTrials.gov Identifier: NCT02400346 |
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Recruitment Status :
Completed
First Posted : March 27, 2015
Results First Posted : June 26, 2017
Last Update Posted : August 10, 2017
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Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depression Disorder | Drug: Adjunct brexpiprazole Drug: ADT | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 132 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | March 2015 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
MedlinePlus related topics:
Antidepressants
Drug Information available for:
Brexpiprazole
| Arm | Intervention/treatment |
|---|---|
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Experimental: Adjunct brexpiprazole
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
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Drug: Adjunct 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. Drug: ADT Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label |
Primary Outcome Measures :
- Number of Patients With Treatment-Emergent Adverse Events [ Time Frame: Baseline to 30 weeks ]Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
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• 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:
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• 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400346
Locations
Show 34 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT02400346 |
| Other Study ID Numbers: |
16160A 2014-003547-35 ( EudraCT Number ) |
| First Posted: | March 27, 2015 Key Record Dates |
| Results First Posted: | June 26, 2017 |
| Last Update Posted: | August 10, 2017 |
| Last Verified: | July 2017 |
Additional relevant MeSH terms:
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Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders Brexpiprazole Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Dopamine Agonists Dopamine Agents |