Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued
that mixed states were the most common episodes in manic-depressive illness. A mixed state is
defined as a person who is experiencing symptoms of both depression and mania.
Currently, a person must have depression plus 3 or more manic symptoms for the episode to be
diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar
disorder would meet criteria for a mixed episode. A broader view requires that the person
have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of
episodes in bipolar disorder would be diagnosable as mixed states.
Studies suggest that the majority of persons with a depressive mixed state have bipolar
disorder type II. Many people who have a mixed state will also have major depression. Even
with such high potential rates of mixed episodes in both bipolar disorder and major
depression, there have been few studies addressing the issue.
The purpose of this study is to look at how effective Geodon is in treating the depressive
mixed state in people with bipolar or major depression. This will be the first clinical trial
that is both double-blind and randomized.