Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients with Major Depressive Disorder

What we are studying

The purpose of this research study is to evaluate the drug levomilnacipran extended-release (ER) for efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) compared to placebo (an inactive substance) in adolescents (12-17 years of age) with depression.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • Hispanic or Latino
  • Ages 12 - 17

Eligibility Criteria

  • Patients must have normal physical examination findings
  • Vital sign values
  • Clinical Laboratory test results
  • And electrocardiogram (ECG) results or abnormal results that are judged not clinically significant by the Investigator
  • Patients must meet DSM-IV-TR criteria for MDD
  • Confirmed by K-SADS-PL
  • Female patients must have a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result at Visit 1

What is involved

  • Vital Signs
  • Electrocardiograms
  • Physical Examination
  • Questionnaires
  • Blood collections

Compensation

$300.00 if all visits attended

Contact Information

Study Coordinator
Ifeoma Onwurah
Email
IONWURAH@wakehealth.edu
Phone
336-716-5113
Principal Investigator
James Kimball, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.