Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Public ClinicalTrials.gov record NCT00490542. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Double-blind, Placebo-controlled Trial of Ziprasidone (Geodon) for the Depressive Mixed State
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00490542
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2006 (Type not available)
- Primary completion
- Aug 2009 (Actual)
- Completion
- Aug 2009 (Actual)
- Last update posted
- Jul 29, 2016
2006 – 2009
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60201 | — |
| Tufts University | Boston | Massachusetts | 02111 | — |
| Cambridge Health Alliance | Cambridge | Massachusetts | 02139 | — |
| Duke University | Durham | North Carolina | 27704 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00490542, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2016 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00490542 live on ClinicalTrials.gov.