401 Study: Trial of Assessing the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression)

Brief Description Of Study

We are looking for people who are currently experiencing major depressive episodes associated with bipolar I or bipolar II disorder to take part in our bipolar depression studies. These clinical research studies are designed to help us learn more about an investigational medication for symptoms of bipolar depression.

Clinical Study Identifier: TX4736

Detailed Study Description

The 401 Study is a randomized, double-blind, placebo-controlled study which is looking at whether an investigational medication, called ITI-007, can improve the symptoms of bipolar depression (bipolar I or bipolar II disorder). It also aims to look at how safe the investigational medication is and whether it impacts the quality of life and well-being of people with bipolar depression.

Additional Information About The Study

You may be able to take part in the 401 Study if you: • are between 18 and 65 years of age (inclusive) • have been diagnosed with bipolar I or bipolar II disorder • are currently having a major depressive episode that started at least 2 weeks ago, but no more than 6 months ago • have previously had at least one bipolar manic episode or mixed episode (if you have bipolar I disorder) or hypomanic episode (if you have bipolar II disorder). Study participation will last up to 12 weeks and will require nine visits to the study center.

Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: 401 Study: Trial of Assessing the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients with Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder (Bipolar Depression)
I am hoping to hear back from you and discuss details of the study

By clicking "Contact Research Team", your contact information will be sent directly to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.