Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)
Brief description of study
The main purpose of this study is to see if the experimental drug ALKS 5461 helps treat depression when used together with an antidepressant medication. Other purposes of this study are to learn more about how safe ALKS 5461 is and how long it stays in the body.
The study drugs that will be given in this study are:
• ALKS 5461 – an experimental drug
• Placebo – a tablet that looks just like ALKS 5461 but contains no active drug
Detailed description of study
Some subjects will already be on an antidepressant medication when they start the study. Other subjects will start a new antidepressant medication during the study. For subjects who stay on the same antidepressant medication that they have already been taking, the overall duration of the study will be about 16 weeks. For subjects who start a new antidepressant medication during the study, the overall duration of the study will be about 24 weeks.
The study is divided into 4 phases: Screening, Lead-In Period, Treatment Period, and Follow-Up Period.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Depression, Depression, medication, drug therapy
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Age: Between 18 Years - 70 Years
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Gender: All
Updated on
06 Nov 2015.
Study ID: TX340
