Study for Adults with Major Depressive Disorder with Sleep Disturbance

National Clinical Trial Number:

NCT04532749

Clinical Trial Protocol Description:

Clinical Trial Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Investigational Drug as Adjunctive Treatment to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Sleep Disturbance Who Have Responded Inadequately to Antidepressant Therapy

This is a 6-week, multicenter, randomized clinical trial (treatment group is assigned by chance). The purpose of the study is to assess the effectiveness and safety of an investigational drug compared to placebo as an add-on therapy in adult participants with major depressive disorder and symptoms of insomnia. The duration of participation will be approximately 12 weeks.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are 18 to 74 years of age.
  • Have major depressive disorder with sleep disturbance.
  • Have an inadequate response to antidepressant therapy.

You will be excluded from the study if any of the following criteria apply to you:

  • Are a female who is pregnant or breastfeeding.
  • Have certain other psychiatric disorders or unstable medical conditions.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

John Zajecka MD

Contact Information

Linda Skaggs