Clinical Study

Rapastinel As An Added Therapy In Major Depressive Disorder

Posted Date: Sep 9, 2017

  • Investigator: Erik Nelson
  • Co-Investigator: Sireesha Pothukuchi
  • Specialties: Depression, Psychiatry/Psychology
  • Type of Study: Drug

The purpose of this research study is to help understand how well experimental Rapastinel works to treat Major Depressive Disorder (MDD). “Experimental” means that the study drug is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA). We will look at how well it can treat symptoms of a major depressive episode while a person is on a stable dose of another antidepressant therapy (ADT). We will also look at any side effects which may occur with Rapastinel when in actual use. Rapastinel is a drug that is injected into a vein. In two Phase 2 clinical trials in patients with MDD; single doses of Rapastinel 5 mg/kg and 10 mg/kg produced noticeable antidepressant effects within 1 day that lasted approximately 1 week or longer in responding patients. You are being asked to take part in this study because you have been diagnosed with major depressive disorder, and have not had an adequate treatment response to previous treatment. The purpose of this research study is to evaluate the efficacy (how well the drug works), safety and tolerability (the side effects) of Rapastinel compared to placebo in subjects with major depressive disorder who are also receiving an approved antidepressant. A placebo is a medically inactive substance that looks like study treatment, but does not contain the active ingredients. This research study will enroll 700 people with MDD. Approximately 35 centers in the United States will enroll subjects.

Criteria:

To Be Considered For Enrollment Into The Study You Must: • Be Between 18 And 65 Years Of Age • Give Written Informed Consent • Have A Diagnosis Of Major Depressive Disorder • Be On An Ongoing Stable Dose Of A “Protocol Allowed” Adt That Is Not Fully Taking Care Of Your Mdd Symptoms • Meet All Of The Additional Relevant Inclusion Criteria • Understand The Study Instructions, And Be Willing And Able To Follow The Study Instructions. • You Will Not Be Able To Participate In The Study If You Are A Woman Who Is Pregnant, Nursing, Or Planning A Pregnancy. • You Will Not Be Able To Participate In This Study If You Have An Alcohol Or Substance Abuse Disorder (Other Than Nicotine Or Caffeine). • You Are A Woman Of Childbearing Potential, Not Using A Reliable Means Of Contraception. If You Become Pregnant While Participating In The Study, The Sponsor Of The Study May Need Access To Your Medical Records Regarding Your Pregnancy And The Outcome Of Your Pregnancy. • You Have Other Conditions Or Required Treatments That The Study Doctor Deems May Interfere With Your Study Treatment

Keywords:

Ketamine, Major Depressive Disorder, Depression, Null, Null

For More Information:

Jade Lord
513-558-4997
lordje@ucmail.uc.edu

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