Phase 2 N=73 Randomized Double-blind Treatment

Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State

Bipolar Disorder · Bipolar Depression · Depression

Bottom Line

View on ClinicalTrials.gov: NCT00490542 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. — 11.4; 5.9 Scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ziprasidone (Geodon) (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tufts Medical Center
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.	11.4; 5.9	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00490542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.