Summary:
A randomized, double-blind, parallel-group, placebo-controlled, active-referenced, flexible dose study on the efficacy of lu aa21004 on cognitive dysfunction in adult subjects with major depressive disorder (MDD). A 3 month long study with 7 office visits.
Qualified Participants Must:
• Be in the opinion of the investigator, capable of understanding and complying with protocol requirements
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When applicable, have the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
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Have recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI) V6.0.0
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Have received prescribed treatment for a previous episode of depression
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Have a MADRS total score ≥26
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Report subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things)
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Have a reported duration of the current major depressive episode (MDE) for at least 3 months
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Be 18-65 years of age
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A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after completion of the study
Qualified Participants May Receive:
Study medication, free lab work, ECG and compensation for time and travel.