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Trial record 80 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02400346
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : June 26, 2017
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Major Depression Disorder Drug: Adjunct brexpiprazole Drug: ADT Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
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 related topics: Antidepressants

Arm Intervention/treatment
Experimental: Adjunct brexpiprazole
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 identifier (NCT number): NCT02400346

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Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S 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
Antidepressive Agents
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents