Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Condition: Bipolar Disorder; Bipolar Depression; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      We plan on enrolling 25 subjects from each of the four sites. After signing a consent form,
      subjects will be screened and asked to have a physical and specific safety labs done to make
      sure they can safely participate in the study. After the screening visit, subjects will be
      randomly, like a flip of a coin, placed into one of two groups. One group will get the study
      drug, Geodon. The other group will get placebo, a sugar pill. Neither the doctor nor subject
      will know in which group the subject has been placed.

      Subjects will see the doctor once a week for 6 weeks. During each visit, we will check and
      treat any side effects. We will ask questions about mood and go through a number of rating
      scales and assessments that will look at mood and symptoms. Subjects will also fill out
      questionnaires at each visit to assess their moods and see how the study is going. At the
      final visit, subjects will have the same physical exam and lab tests done as in the initial
      visit.
    

Intervention name(s): ziprasidone (Geodon); placebo
Intervention type(s): Drug; Drug
Intervention description(s): ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.; Placebo, sugar pill arm. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Major Depression; Clinical pharmacology; Clinical Trial