Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole as Adjunctive Therapy in the Maintenance Treatment of Adults With Major Depressive Disorder

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Study Overview

You are being asked to take part in this study because you have been diagnosed with major depressive disorder (depression). Brexpiprazole is a medication being studied as a possible treatment for adjunctive treatment for Major Depressive Disorder (MDD). It was first approved in the United States (10 July 2015) for the treatment of schizophrenia and as an adjunctive therapy (add-on therapy) to antidepressants for the treatment of major depressive disorder.

The reason for this study is to find out about the potential benefits, tolerability and safety of brexpiprazole as an adjunctive therapy to your current antidepressant.

Study Description

If you decide to join, you will be asked to sign this consent form. By signing this form, you agree to follow the instructions given by the research staff during the study. Once you sign the form, the study doctor and staff will review your medical records, check some details with you and perform some tests to confirm if you are appropriate for the study. These tests can take up to 42 days to complete.

You will be notified by the study staff if you are approved by the study doctor to participate.

If you are confirmed appropriate for the study, you will have the first treatment visit and be given your assigned study medication to begin taking.

The study is broken into 3 phases. Phase A lasts for 6-8 weeks with a total of 9 visits and at the end of this period depending upon how you are doing, you might continue in the next phase.

If you meet certain criteria at the end of phase A, you may be eligible to continue in 12 weeks long phase B which includes a total of 12 visits.

Depending on your response to the study drug and if you continue to meet study criteria at the end of phase B, you may be eligible to participate in the next 26 weeks long phase C of the study with 9 visits to the clinic and a follow up visit over the phone.

If you cannot tolerate the dose of study medication (or matching placebo) you are given, you will be discontinued from the study.

The total time you would participate in the study may be up to 49 weeks including a safety follow-up contact 3 weeks after treatment completion.

  • Study Identifier: 331-201-00079

Recruitment Status

Open

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