402 Study: Trial of Assessing the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate 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.
Detailed Study Description
The 402 study is a randomized, double-blind, placebo-controlled research 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, when it is added to existing treatment with a mood stabilizer, specifically lithium or valproate.
Additional Information About The Study
You may be able to take part in the 402 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.