Expired Study
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Clinical Trial 8481

Los Angeles, CA 90024

Study Summary:

The purpose of this study is to evaluate the efficacy of Lu AA21004, once daily (QD), compared with placebo in adults with major depressive disorder. The study is 3 months.

Inclusion Criteria:

  • Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
  • Has a MADRS total score of 26 or greater at Screening and Baseline Visits.
  • Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
Exclusion Criteria:
  • Has received Lu AA21004 in a previous clinical study.
  • Has 1 or more the following:
  • Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
  • Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
  • Any substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR.
  • Presence or history of a clinically significant neurological disorder (including epilepsy)
  • Neurodegenerative disorder.
  • Any Axis II disorder that might compromise the study.
  • Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
  • Has clinically significant abnormal vital signs as determined by the investigator.
  • Has an abnormal Electrocardiogram.
  • Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
  • Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
  • Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
  • Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
  • Has a clinically significant unstable illness.
  • Has a significant risk of suicide according to the investigator's opinion.

  • Qualified Participants Must:

    • Be 18 to 75 years of age

    Qualified Participants May Receive:

    Free diagnostic assessments, physicals, ECG, lab work, and $50 compensation at each visit.

    Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.