Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
NCT00237666
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | ||||
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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:
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 |
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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 | 30 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |