Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Condition: Bipolar Disorder; Bipolar Depression; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: ziprasidone (Geodon); placebo
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Major Depression; Clinical pharmacology; Clinical Trial

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar disorder type II, or unipolar major depressive disorder

          -  If female, non-pregnant/non-lactating

          -  If a sexually active female of reproductive potential, must be using adequate
             contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)

          -  Currently meets Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for a
             major depressive episode, and presence of 2 or 3 DSM-IV manic criteria, present for
             the majority of the time during the past week.

          -  All other baseline psychotropic drugs will be allowed to be continued unchanged.
             However, if antidepressant use has been initiated in the previous 2 months, or was
             thought to be contributing to the depressive mixed state, then antidepressant
             medications would be discontinued 4 weeks before starting the study.