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

NCT00490542

Last updated date
Study Location
Northwestern University
Chicago, Illinois, 60201, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Bipolar Depression, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

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Bipolar Disorder, Bipolar Depression, DepressionSafety Study of Ziprasidone (Geodon) for the Depressive Mixed State
NCT00490542
  1. Chicago, Illinois
  2. Boston, Massachusetts
  3. Cambridge, Massachusetts
  4. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
Official Title  ICMJE Double-blind, Placebo-controlled Trial of Ziprasidone (Geodon) for the Depressive Mixed State
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Bipolar Depression
  • Depression
Intervention  ICMJE
  • Drug: ziprasidone (Geodon)
    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.
  • Drug: placebo
    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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo arm
    Participants were instructed by a physician to take a study drug daily. 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. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received sugar pills.
    Intervention: Drug: placebo
  • Active Comparator: Geodon arm
    Participants were instructed by a physician to take a study drug daily. 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. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received Geodon.
    Intervention: Drug: ziprasidone (Geodon)
Publications * Patkar A, Gilmer W, Pae CU, Vöhringer PA, Ziffra M, Pirok E, Mulligan M, Filkowski MM, Whitham EA, Holtzman NS, Thommi SB, Logvinenko T, Loebel A, Masand P, Ghaemi SN. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state. PLoS One. 2012;7(4):e34757. doi: 10.1371/journal.pone.0034757. Epub 2012 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2013)
73
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2007)
100
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00490542
Other Study ID Numbers  ICMJE GA128000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Nassir Ghaemi, MD, MPHTufts University
PRS Account Tufts Medical Center
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP