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)

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.

FAQ

You may be able to take part in the 402 Study if you: • are between 18 and 75 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.

Details