Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

NCT00237666

Last updated date
Study Location
Medical Research Network, L.L.C.
New York, New York, 10024, 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 II Disorder, Major Depressive Episode
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania

- patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration

- minimum score of 18 on the 17-item HAM-D at screen and baseline

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- patients will not meet criteria for Bipolar I or Schizoaffective Disorder or
Schizophrenia


- patients may have co-morbid anxiety or other Axis I disorders as long as depression
dominates the clinical picture


- Suicidal ideation or history that makes participation in a clinical trial unduly risky


- unstable medical conditions or any abnormality in thyroid function


- patients with a QTc of 450msec or greater on the initial ECG


- patients requiring concomitant psychotropic drugs will not be eligible, although
patients on such drugs who can undergo washout will be eligible. such patients must
have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4
weeks for fluoxetine and depot neuroleptics


- the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from
insomnia, but cannot be taken the night before a scheduled assessment


- patients with dementia or substance abuse in the last 6 months


- pregnant or lactating women will be excluded, as will those not using adequate forms
of contraception

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Bipolar II Disorder, Major Depressive EpisodeOpen-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
NCT00237666
  1. New York, New York
  2. Plano, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Official Title  ICMJE An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression
Brief Summary The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.
Detailed Description

Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:

  • antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
  • Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
  • even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
  • antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
  • non-response and loss of response are common reactions to antidepressants in Bipolar II patients

This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.

This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.

Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar II Disorder
  • Major Depressive Episode
Intervention  ICMJE Drug: Ziprasidone
Ziprasidone 20-60 mg BID, taken orally.
Other Name: Geodon
Study Arms  ICMJE Experimental: Ziprasidone
Ziprasidone monotherapy, 20-60 mg BID.
Intervention: Drug: Ziprasidone
Publications * Not Provided

*   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: October 18, 2005)
30
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
20
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
  • patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
  • minimum score of 18 on the 17-item HAM-D at screen and baseline

Exclusion Criteria:

  • patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
  • patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
  • Suicidal ideation or history that makes participation in a clinical trial unduly risky
  • unstable medical conditions or any abnormality in thyroid function
  • patients with a QTc of 450msec or greater on the initial ECG
  • patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
  • the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
  • patients with dementia or substance abuse in the last 6 months
  • pregnant or lactating women will be excluded, as will those not using adequate forms of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 NCT00237666
Other Study ID Numbers  ICMJE 04-3945-A 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Medical Research Network
Study Sponsor  ICMJE The Medical Research Network
Collaborators  ICMJE
  • Liebowitz, Michael R., M.D.
  • Pfizer
Investigators  ICMJE
Principal Investigator:Michael R Liebowitz, MDMedical Research Network, L.L.C.
PRS Account The Medical Research Network
Verification Date May 2013

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