Status:
COMPLETED
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Lead Sponsor:
The Medical Research Network
Collaborating Sponsors:
Liebowitz, Michael R., M.D.
Pfizer
Conditions:
Bipolar II Disorder
Major Depressive Episode
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 e...
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 hypo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00237666
Start Date
February 1 2005
End Date
February 1 2008
Last Update
June 19 2013
Active Locations (2)
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1
Medical Research Network, L.L.C.
New York, New York, United States, 10024
2
The Mech Center
Plano, Texas, United States, 75024